Trending Topics & Drug Approvals: May 2025 - Prime Therapeutics
Trending Topics & Drug Approvals: May 2025
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The United States (U.S.) Food and Drug Administration (FDA) has cleared for marketing the first blood test to aid in diagnosing Alzheimer’s disease (AD): Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. The test measures two proteins, pTau217 and β-amyloid 1-42, found in human plasma and is for early detection of amyloid plaques associated with AD in patients ≥ 55 years of age with signs and symptoms. The numerical ratio of the two proteins is calculated and then correlated to the presence or absence of amyloid plaques in the patient’s brain. In contrast to other FDA-cleared tests that require cerebrospinal fluid (CSF) samples taken via lumbar puncture, only a blood draw is required for Lumipulse. Clinical study results included 499 individual plasma samples and demonstrated that Lumipulse can reliably predict amyloid pathology associated with AD in patients who are cognitively impaired. A total of 91.7% of patients with positive results had the presence of amyloid, and 97.3% of patients with negative results were negative for amyloid based on positron emission tomography (PET) scan or CSF test results. Lumipulse is not intended for use as a screening or standalone diagnostic. Results require interpretation in conjunction with other patient clinical information (e.g., clinical evaluations, additional tests); the new blood test may reduce the need for a PET scan in patients with signs and symptoms of cognitive decline. Fujirebio Diagnostics’ Lumipulse received Breakthrough Device Designation and was reviewed through the 510(k) premarket notification pathway.
The FDA has issued a Drug Safety Communication on the risk of severe itching (pruritus) following discontinuation of long-term daily use of oral allergy medications (e.g., cetirizine [Zyrtec], levocetirizine [Xyzal]). The product labeling for prescription cetirizine and levocetirizine will be updated to include a new warning regarding this risk, and manufacturers of over-the-counter products will be required to make corresponding updates to the Drugs Fact Label. A total of 209 worldwide cases (197 in the U.S.) were reported to the FDA between April 2017 and July 2023. Many patients reported widespread pruritus requiring medical intervention. Although the overall incidence is rare and the mechanism is unknown, the FDA concluded there is a causal relationship between discontinuation of these medications and pruritus. Apart from prolonged use, the FDA has not identified any risk factors following discontinuation. Furthermore, restarting the medication resolved the pruritus in the majority of individuals, and some were able to taper off these medications with continued symptom resolution.
The U.S. Centers for Disease Control and Prevention’s (CDC’s) National Center for Health Statistics published a data brief on the prevalence of depression in adolescents and adults in the U.S. from August 2021 to August 2023. Depression was defined by a score of ≥ 10 on the 9-item Patient Health Questionnaire (summary scores, 0 to 27), which is a validated screening instrument for self-reported depressive symptoms. The overall prevalence of depressive symptoms in individuals ≥ 12 years of age in the prior two weeks was 13.1%. Prevalence decreased as patient age increased and was highest in those 12 to 19 years of age (19.2%) and lowest in adults ≥ 60 years of age (8.7%). The prevalence of depression also decreased as family income increased. Females (16%) exhibited a higher prevalence than males (10.1%) for all age groups with the exception of ages 20 to 39 years (19% versus 14.3%, respectively) where the difference was not significant. In adolescents 12 to 19 years of age, prevalence in females was more than twice that in males in the same age range (26.5% versus 12.2%). From 2013-2014 to August 2021-August 2023, the prevalence of depression increased similarly for females and males ≥ 12 years of age from 8.2% to 13.1%. The majority of individuals (87.9%) with depression reported challenges with work, home or social activities due to symptoms of their depression. However, only 39.3% of patients with depression received counseling or therapy from a mental health professional in the prior 12 months, with more females (43%) than males (33.2%) receiving these services.
Results have been published in The New England Journal of Medicine for the Phase 3b, multicenter, open-label, controlled SURMOUNT-5 trial (n=751) comparing tirzepatide (Zepbound) to semaglutide (Wegovy) in adults who had a body mass index (BMI) of ≥ 30 kg/m2 or a BMI of ≥ 27 kg/m2 and at least one obesity-related complication (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) and who had reported at least one unsuccessful dietary effort for weight reduction; patients with diabetes were excluded. Patients were randomized to receive either a maximum tolerated dose of tirzepatide (10 mg or 15 mg) or the maximum tolerated dose of semaglutide (1.7 mg or 2.4 mg) subcutaneously (SC) once weekly for 72 weeks. The primary endpoint assessing the least-squares (LS) mean percent change in weight from baseline to week 72 was significantly reduced with tirzepatide (-20.2%; 95% confidence interval [CI], -21.4 to -19.1) compared to semaglutide (-13.7%; 95% CI, -14.9 to -12.6) (p<0.001). Furthermore, the LS mean change in waist circumference was also significantly reduced with tirzepatide (-18.4 cm; 95% CI, -19.6 to -17.2) compared with semaglutide (-13 cm; 95% CI, -14.3 to -11.7) (p<0.001).
A study published in BMC Ophthalmology reviewed data extracted from the U.S. FDA Adverse Event Reporting System (FAERS) database from Q1 2004 through Q3 2024 for adverse drug reactions associated with use of semaglutide. There were 1,733 ocular adverse drug event (ADE) reports with 1,541 being associated with injectables and 192 associated with tablets. Although most reported events occurred within the first month of administration for both dosage forms, the median time to onset with injectables was seven days compared to three and a half days for the tablets. Female patients appeared to have a higher susceptibility for ocular adverse reactions compared to males. More than a third of the total ocular ADEs associated with the tablet formulation were blurred vision, which was marginally higher than seen with the injectable formulation. In contrast, the injection formulation had a higher frequency of reports regarding retinal complications (e.g., diabetic retinopathy, ischemic optic neuropathy, retinal detachment, retinal tear, retinal hemorrhage).
Novo Nordisk announced a collaboration with select telehealth providers that expands access to semaglutide (Wegovy). The telehealth providers are Hims & Hers Health, LifeMD and Ro. The collaboration provides a simplified pathway to NovoCare Pharmacy, which was launched in March 2025 to provide direct-to-consumer, home shipments at the reduced cost of $499 per month for self-paying patients. CenterWell Pharmacy is the dispensing pharmacy that is managing fulfillment and delivery for NovoCare Pharmacy.
Results from a population-based cohort study based on claims data for adults from a large U.S. commercial database from January 2021 to December 2023 have been published in the Annals of Internal Medicine. During this timeframe, there was a marked increase in tirzepatide dispensing, accounting for 12.3% of all glucose-lowering medication dispensing by December 2023. Both tirzepatide and semaglutide showed substantial increases in dispensing among adults without diabetes who were prescribed weight-lowering medications (0% to 40.6% for tirzepatide and 0% to 32.2% for 2.4 mg of semaglutide). However, the most frequently dispensed weight-lowering medication was 2 mg semaglutide (37.8% to 45.7%). Dispensing of other weight-lowering medications decreased. Dispensing of sodium-glucose cotransporter-2 inhibitors increased (14.5% to 24.4%), as did dispensing of glucagon-like peptide-1 agonists (GLP-1s) (19.5% to 28.5%); however, dispensing of other glucose-lowering medications (e.g., metformin) decreased.
Novo Nordisk’s liraglutide (Saxenda) for weight management continues to have limited availability due to increased demand for the drug, and liraglutide (Victoza), the formulation indicated for select patients with type 2 diabetes mellitus (T2DM), also continues to have limited availability due to a delay in shipping of the drug; an authorized generic of Victoza distributed by Teva is available. A generic version of Victoza from Hikma will be available upon release of the product from the manufacturer; Meitheal also has generic product available. Eli Lilly’s dulaglutide (Trulicity) continues to be available. Novo Nordisk’s semaglutide (Ozempic, Wegovy) and Eli Lilly’s tirzepatide (Mounjaro, Zepbound) remain on the FDA’s “resolved” shortages list. Based on the timeline previously established for compounders by the FDA, outsourcing facilities can no longer compound, distribute or dispense semaglutide injection after May 22, 2025. In April 2025, a district court denied a preliminary injunction motion in Outsourcing Facilities Association v. FDA; as a result, the previously established timeline remains in place.
Shortages of stimulants for the treatment of attention-deficit/hyperactivity disorder (ADHD) continue to be reported. Availability of generic methylphenidate hydrochloride (HCl) extended-release (ER) tablets is variable depending on the manufacturer. Brand name Relexxii from Vertical has limited availability due to increased demand; brand name Concerta from Janssen is currently available. Most strengths of methylphenidate ER film (Daytrana, authorized generic) are unavailable due to shortage of an active ingredient. Generic amphetamine aspartate monohydrate, amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate immediate release (IR) tablet shortages are also being reported; all strengths of brand-name Adderall IR tablets from Teva are available. Shortages of the generic version of Vyvanse, lisdexamfetamine dimesylate capsules and chewable tablets, persist. Brand name Vyvanse capsules and chewable tablets remain available from Takeda.
On May 20, 2025, the FDA published a new regulatory framework for coronavirus disease 2019 (COVID-19) vaccines in the U.S. based on immunogenicity. Going forward for approval of COVID-19 vaccines, the Agency anticipates the benefit to risk profile will favor receipt of COVID-19 vaccination for adults ≥ 65 years of age and for all persons > 6 months with one or more risk factors that increase the risk for severe COVID-19 outcomes. However, for those with no risk factors for severe COVID-19 who are 6 months to 64 years of age, the FDA anticipates randomized, controlled trials assessing clinical outcomes will be required before approval in this population. On May 22, 2025, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened in open session for discussion and recommendations on the selection of the 2025 to 2026 formula for COVID-19 vaccines; a monovalent JN.1-lineage vaccine composition was unanimously recommended. The U.S. Department of Health and Human Services (HHS) has announced the COVID-19 vaccine has been removed from the CDC immunization schedule for healthy children and healthy pregnant women.
The FDA and CDC are recommending a pause in the use of Chikungunya Vaccine, Live (Ixchiq) in individuals ≥ 60 year of age while the agencies investigate postmarketing reports of serious adverse events (e.g., neurologic and cardiac events). As of early May 2025, 17 serious adverse events, two of which resulted in death, have been reported in persons 62 through 89 years of age who received Ixchiq globally (six of these events occurred in the U.S.). Most events have been in persons with underlying chronic medical conditions; these events may not be causally related to vaccination. The agencies will provide additional communication once the safety evaluations are completed.
The FDA issued an alert regarding potential risks associated with compounded topical finasteride products as certain compounders and telemedicine agencies have been marketing topical formulations of finasteride alone or in combination with other ingredients (e.g., minoxidil) for hair loss. Although there are currently two FDA-approved oral finasteride products (Proscar, Propecia), there is not an FDA-approved topical formulation of finasteride. From 2019 to 2024, the FAERS received 32 cases of adverse events (e.g., erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido, testicular pain) with most adverse events persisting following product discontinuation. The FDA is recommending (1) that health care professionals (HCPs) provide education to patients on potential risks of compounded topical finasteride, including the risk of inadvertent exposure from transferring to female individuals, and (2) that consumers consult with HCPs and compounders about potential risks before starting use of compounded topical finasteride.
The FDA has announced action will be taken to remove concentrated ingestible fluoride prescription drug products for children from the U.S. market. These products have not been approved by the FDA and are swallowed by infants/toddlers which can, according to the FDA, alter the gut microbiome. The HHS also will disseminate best practices for dental hygiene in children that are feasible and effective. By Oct. 31, 2025, the FDA plans to have completed the safety review and public comment period and have taken appropriate action for the removal of these products from commercialization.
Marketing authorization was granted by the FDA to CT-132, the first prescription digital therapeutic for preventive treatment of episodic migraine in adults. It is intended for use as an adjunct to acute and/or other preventive migraine treatments. Prescription digital therapeutics provide treatment directly to a patient via their smartphone through a mobile application (app). Click Therapeutics’ CT-132 was authorized based on the ReMMi-D (Reduction in Monthly Migraine Days; n=568) study that demonstrated a significant reduction in monthly migraine days (MMDs) after 12 weeks of CT-132 compared to sham (treatment difference, -0.9 MMDs; p=0.005).
The CDC reports, as of May 30, 2025, there were 1,088 confirmed cases of measles in the U.S. Cases include 322 in individuals < 5 years of age, 407 in those 5 to 19 years of age, 349 in those ≥ 20 years of age and ten with unknown age. The vast majority (96%) of cases are among individuals with unvaccinated or unknown vaccination status. The CDC published a Morbidity and Mortality Weekly Report (MMWR) on measles cases between Jan. 1, 2025, and April 17, 2025. A total of 11% of the 800 reported cases during this time period required hospitalization, and three deaths occurred.
The CDC has published an MMWR on recommendations for antiretroviral (ARV) postexposure prophylaxis (PEP) after nonoccupational exposure to human immunodeficiency virus (HIV) (e.g., sexual, injection drug use, other forms of nonoccupational exposure). The new guidance replaces the 2016 guidance and includes newer ARV agents, updated considerations for PEP indications and emerging implementation approaches. Considerations for testing are also included, as well as PEP regimens for persons exposed who have received long-acting injectable ARVs in the past.
Drug Approvals
Specialty
April 28, 2025 – prademagene zamikeracel (Zevaskyn) (also known as pz-cel)
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Biologics License Application (BLA) approval; Priority Review, Rare Pediatric Disease; approval marks the first autologous cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic condition leading to extremely fragile skin with blisters and chronic painful wounds due to absent or low levels of biologically active collagen 7 (C7) protein which form anchoring fibrils (without anchoring fibrils, the connection between the epidermis and dermis is disrupted)
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Autologous cell sheet-based gene therapy
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Indicated for the treatment of wounds in adult and pediatric patients with RDEB
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Cellular sheets: each measuring 41.25 cm² (5.5 cm by 7.5 cm) and consisting of the patient’s own viable, gene-modified cells that contain functional copies of the COL7A1 gene that express C7 protein (up to 12 sheets may be manufactured from the patient biopsies); shipped directly to the qualified treatment center sealed in transport packaging
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Recommended dosage is based on surface area of the wound(s); all selected sheets should be applied topically in a single surgical session under general or other appropriate anesthesia
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Approval was based on a multicenter, randomized, intrapatient-controlled, Phase 3 study (VIITAL; n=11 [86 wounds]) that compared pz-cel to standard of care (SOC) wound dressings in matched wound pairs; pz-cel demonstrated a significant improvement in wound healing and pain reduction following a single treatment at month six compared to control as measured by the proportion of randomized wound pairs healed ≥ 50% from baseline (81% versus 16%, respectively; p<0.0001) and mean pain reduction from baseline as measured by patient-reported pain scores using the Wong-Baker FACES scale (-3.1 versus -0.9, respectively; p=0.0002)
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Beremagene geperpavec-svdt (Vyjuvek) is indicated for the treatment of wounds in patients ≥ 6 months of age with dystrophic epidermolysis bullosa with mutation(s) in the COL7A1 gene; it is an HSV-1 vector-based gene therapy supplied as a biological suspension mixed with excipient gel for topical application; the gel is applied once a week to selected wound(s) in droplets spaced evenly within the wound (1 cm by 1 cm apart); it requires a health care professional (HCP) to apply either in a clinic or home setting
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Zevaskyn will be available from Abeona through qualified treatment centers beginning in Q3 2025
April 29, 2025 – nipocalimab-aahu (Imaavy)
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BLA approval; Orphan Drug, Priority Review
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Neonatal Fc receptor (FcRn) blocker
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Indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients ≥ 12 years of age who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
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Solution for injection: 300 mg/1.62 mL and 1,200 mg/6.5 mL single-dose vials
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Recommended initial dosage is weight-based and given once via intravenous (IV) infusion, followed by a weight-based maintenance dosage given via IV infusion two weeks later, and continued every two weeks thereafter; administered by an HCP with monitoring of the patient for 30 minutes following each infusion for infusion-related or hypersensitivity reactions
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Approval was based on a randomized, double-blind, placebo-controlled, Phase 3 study (Vivacity-MG3; n=196) that enrolled adults with gMG inadequately controlled with SOC therapy (acetylcholinesterase [AChE] inhibitors, steroids or non-steroidal immunosuppressive therapies [NSISTs], either in combination or alone); at week 24, there was a significant improvement in the least squares (LS) mean change from baseline for the Myasthenia Gravis Activities of Daily Living (MG-ADL) total score (range, 0 to 24; higher scores indicating more impairment) averaged over weeks 22, 23 and 24 with nipocalimab and SOC compared to placebo and SOC (-4.7 versus -3.3; LS mean difference, -1.5; 95% confidence interval [CI], -2.4 to -0.5; p=0.002)
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Other medications with similar mechanisms of action and indications include the monoclonal antibody rozanolixizumab-noli (Rystiggo), a subcutaneous (SC) FcRn blocker which shares the same indication as Imaavy but is only indicated for use in adults and efgartigimod alfa-fcab (Vyvgart), an IV antibody fragment that binds to the FcRn and is indicated for gMG in adult patients who are AChR antibody positive; efgartigimod alfa is also approved as a SC formulation with hyaluronidase-qvfc (Vyvgart Hytrulo) which has the same indication as Vyvgart
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Imaavy is available from Janssen
May 8, 2025 – avutometinib capsules; defactinib tablets (Avmapki Fakzynja Co-pack)
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New Drug Application (NDA) approval; Accelerated Approval, Assessment Aid, Breakthrough Therapy, Orphan Drug, Priority Review, Real-Time Oncology Review (RTOR)
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Combination of kinase inhibitors
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Indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy; the Accelerated Approval was based on tumor response rate and duration of response (DOR), therefore, continued approval for this use may require demonstration of benefit in a confirmatory clinical trial
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Oral co-pack: 0.8 mg avutometinib (Avmapki) capsules and 200 mg defactinib (Fakzynja) tablets
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Recommended dosage is Avmapki orally twice weekly (day one and day four) and Fakzynja orally twice daily; both taken with food for the first three weeks of each four-week cycle until disease progression or unacceptable toxicity
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Approval was based on an open-label, multicenter, Phase 2 study (RAMP-201; n=57) conducted in adults with measurable KRAS-mutated recurrent LGSOC who had received at least one prior systemic therapy, including a platinum-based regimen; the major efficacy outcome of overall response rate (ORR) was 44% (95% CI, 31 to 58) with most responses being partial responses (40%) (complete response, 3.5%); the DOR range was 3.3 months to 31.1 months
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Avmapki Fakzynja Co-pack is the first United States (U.S.) Food and Drug Administration (FDA) approved treatment for adults with KRAS-mutated recurrent low-grade serous ovarian cancer; other treatment options for LGSOC include paclitaxel/carboplatin with or without maintenance letrozole or other hormonal therapy
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Avmapki Fakzynja Co-pack is available from Verastem
May 14, 2025 – telisotuzumab vedotin-tllv (Emrelis)
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BLA approval; Accelerated Approval, Assessment Aid, Breakthrough Therapy, Priority Review, RTOR; the FDA also approved the companion diagnostic device Ventana Met RxDx Assay from Roche to aid in detection of c-Met protein overexpression
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c-Met-directed antibody and microtubule inhibitor conjugate
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Indicated for the treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (≥ 50% of tumor cells with strong [3+] staining), as determined by an FDA-approved test, who have received a prior systemic therapy; the Accelerated Approval was based on ORR and DOR, therefore, continued approval for this use may require demonstration of benefit in confirmatory clinical trials
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For injection: lyophilized powder in 20 mg and 100 mg single-dose vials for reconstitution and further dilution
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Recommended dosage is weight-based and is administered as an IV infusion every two weeks until disease progression or unacceptable toxicity
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Approval was based on a multicenter, open-label, single-arm, multi-cohort, Phase 2 trial (LUMINOSITY; n=78) that demonstrated an ORR of 34.6% (95% CI, 24.2 to 46.2) in high C-Met protein overexpression patients and a median DOR of nine months (95% CI, 4.2 to 13); the median overall survival was 14.6 months (95% CI, 9.2 to 25.6)
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Emrelis is the first FDA-approved treatment for previously treated advanced NSCLC patients with high c-Met protein overexpression; prior therapies patients enrolled in LUMINOSITY received included platinum-based chemotherapy and immune checkpoint inhibitors; in the second-line and greater setting, SOC is usually single-agent chemotherapy (e.g., docetaxel with or without an antiangiogenic agent)
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Emrelis will be available from Abbvie with launch time frame to be determined (TBD)
None
April 30, 2025 – ustekinumab-aauz (Otulfi)
- Supplemental BLA (sBLA) approval; the 45 mg/0.5 mL vial for SC use of ustekinumab-aauz (Otulfi) has received FDA approval as an interchangeable biosimilar to the same presentation of ustekinumab (Stelara); previously, Otulfi was only approved as a biosimilar to Stelara; now one of five FDA-approved interchangeable biosimilars to Stelara
- Human interleukin (IL)-12 and -23 antagonist
- Indicated for adults with (1) moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy, (2) active psoriatic arthritis (PsA), (3) moderately to severely active Crohn’s disease (CD) and (4) moderately to severely active ulcerative colitis; pediatric patients ≥ 6 years of age with (1) moderate to severe PsO who are candidates for phototherapy or systemic therapy and (2) active PsA (same indications as reference drug Stelara)
- Solution for injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe for SC use; 45 mg/0.5 mL solution in a single-dose vial for SC use (interchangeable designation); 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for IV use
- Recommended dosage is based on indication, patient age and body weight
- The interchangeable presentation will be available from Fresenius Kabi with launch time frame TBD
April 30, 2025 – ustekinumab-aekn (Selarsdi)
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sBLA approval; all presentations of ustekinumab-aekn (Selarsdi) have received FDA approval as an interchangeable biosimilar to ustekinumab (Stelara); previously, Selarsdi was only approved as a biosimilar to Stelara; now one of five FDA-approved interchangeable biosimilars to Stelara
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Human IL-12 and -23 antagonist
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Indicated for adults with (1) moderate to severe PsO who are candidates for phototherapy or systemic therapy, (2) active PsA, (3) moderately to severely active CD and (4) moderately to severely active ulcerative colitis; pediatric patients ≥ 6 years of age with (1) moderate to severe PsO who are candidates for phototherapy or systemic therapy and (2) active PsA (same indications as reference drug Stelara)
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Solution for injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe for SC use; 45 mg/0.5 mL solution in a single-dose vial for SC use; 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for IV use (all presentations designated as interchangeable)
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Recommended dosage is based on indication, patient age and body weight
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Product is available from Teva
April 30, 2025 – ustekinumab- kfce (Yesintek)
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sBLA approval; all presentations of ustekinumab-kfce (Yesintek) have received FDA approval as an interchangeable biosimilar to ustekinumab (Stelara); previously, Yesintek was only approved as a biosimilar to Stelara; now one of five FDA-approved interchangeable biosimilars to Stelara
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Human IL-12 and -23 antagonist
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Indicated for adults with (1) moderate to severe PsO who are candidates for phototherapy or systemic therapy, (2) active PsA, (3) moderately to severely active CD and (4) moderately to severely active ulcerative colitis; pediatric patients ≥ 6 years of age with (1) moderate to severe PsO who are candidates for phototherapy or systemic therapy and (2) active PsA (same indications as reference drug Stelara)
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Solution for injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe for SC use; 45 mg/0.5 mL solution in a single-dose vial for SC use; 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for IV use (all presentations designated as interchangeable)
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Recommended dosage is based on indication, patient age and body weight
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Product is available from Biocon
April 30, 2025 – ustekinumab-ttwe (Pyzchiva)
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sBLA and BLA approval; all presentations of ustekinumab-ttwe (Pyzchiva) have received FDA approval as an interchangeable biosimilar to ustekinumab (Stelara); previously, Pyzchiva was only approved as a biosimilar to Stelara; now one of five FDA-approved interchangeable biosimilars to Stelara
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Human IL-12 and -23 antagonist
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Indicated for adults with (1) moderate to severe PsO who are candidates for phototherapy or systemic therapy, (2) active PsA, (3) moderately to severely active CD and (4) moderately to severely active ulcerative colitis; pediatric patients ≥ 6 years of age with (1) moderate to severe PsO who are candidates for phototherapy or systemic therapy and (2) active PsA (same indications as reference drug Stelara)
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Solution for injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe for SC use; 45 mg/0.5 mL solution in a single-dose vial for SC use; 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for IV use (all presentations designated as interchangeable)
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Recommended dosage is based on indication, patient age and body weight
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Product is available from Sandoz
April 23, 2025 – palbociclib (Ibrance)
- Pfizer; kinase inhibitor
- New indication: in combination with inavolisib (Itovebi) and fulvestrant (Faslodex) for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy
- Administered orally once daily with or without food in combination with Itovebi and Faslodex for 21 days followed by seven days off treatment
- Other indications: select adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with other agents depending on place in therapy
April 23, 2025 – pegfilgrastim-pbbk (Fylnetra)
- Kashiv Biosciences; leukocyte growth factor; one of the six biosimilars to pegfilgrastim (Neulasta) and has been approved for one new indication (thereby now approved for all the same indications as reference drug Neulasta)
- New indication: increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome)
- Administered for patients exposed to myelosuppressive doses of radiation as two doses SC one week apart; administer the first dose ASAP after suspected or confirmed exposure to radiation levels > 2 gray (Gy), and a second dose one week after; the dose is weight-based for pediatric patients with a body weight < 45 kg; patients or caregivers can administer following proper training
- Other indication: decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia
April 28, 2025 – upadacitinib (Rinvoq)
- Abbvie; Janus kinase (JAK) inhibitor; first oral JAK inhibitor approved for the treatment of giant cell arteritis (GCA) in adults
- New indication: treatment of adults with GCA; not recommended for use in combination with other JAK inhibitors, biologic disease modifying anti-rheumatic drugs (DMARDs) or with potent immunosuppressants such as azathioprine and cyclosporine
- Administered orally once daily in combination with a tapering course of corticosteroids, then Rinvoq can be continued as monotherapy following discontinuation of corticosteroids
- Other indications: select patients with rheumatoid arthritis, PsA, atopic dermatitis, ulcerative colitis, CD, ankylosing spondylitis, nonradiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis
April 29, 2025 – filgrastim-ayow (Releuko)
- Kashiv Biosciences; leukocyte growth factor; one of the four biosimilars to filgrastim (Neupogen) and has been approved for two new indications (thereby now approved for all the same indications as reference drug Neupogen)
- New indications: (1) mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis and (2) increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome)
- Administered for mobilization of autologous peripheral blood progenitor cells (PBPC) as a weight-based daily SC dose given for at least four days before the first leukapheresis procedure and continued until the last leukapheresis (monitor neutrophil counts after four days of Releuko and discontinue if the WBC count rises to > 100‚000/mm³); for patients exposed to myelosuppressive doses of radiation, the recommended dose is weight-based given as a single daily SC injection administered ASAP after suspected or confirmed exposure to radiation doses > 2 Gy (a baseline CBC and then serial CBCs should be obtained approximately every third day until the ANC remains > 1,000/mm³ for three consecutive CBCs; continue administration until the ANC remains > 1,000/mm³ for three consecutive CBCs or exceeds 10,000/mm³ after a radiation-induced nadir); patients or caregivers can administer following proper training
- Other indications: related to neutropenia and neutrophil recovery
May 14, 2025 – belzutifan (Welireg)
- Merck Sharp & Dohme; hypoxia-inducible factor inhibitor; Assessment Aid, Priority Review; first FDA-approved oral therapy for pheochromocytoma or paraganglioma (PPGL)
- New indication: for treatment of adult and pediatric patients ≥ 12 years of age with locally advanced, unresectable, or metastatic PPGL
- Administered orally once daily with or without food; continued until disease progression or unacceptable toxicity; pediatric dosing is based on body weight (< 40 kg or ≥ 40 kg)
- Other indications: select adults with von Hippel-Lindau disease or advanced renal cell carcinoma
May 15, 2025 – retifanlimab-dlwr (Zynyz)
- Incyte; programmed death receptor-1 (PD-1) blocking antibody; Assessment Aid, Fast Track, Orphan Drug, Priority Review
- New indications: (1) in combination with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and (2) as a single agent for adults with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy
- Administered as an IV infusion every four weeks by an HCP; continued until disease progression, unacceptable toxicity, or up to 12 months (combination therapy) or up to 24 months (monotherapy)
- Other indication: select patients with Merkel cell carcinoma (Accelerated Approval)
May 19, 2025 – antihemophilic factor (recombinant), PEGylated-aucl (Jivi)
- Bayer; recombinant DNA-derived, factor VIII concentrate
- Expanded indication: to include pediatric patients 7 to 11 years of age with hemophilia A (congenital factor VIII deficiency) for (1) on-demand treatment and control of bleeding episodes, (2) perioperative management of bleeding and (3) routine prophylaxis to reduce the frequency of bleeding episodes; previously, indicated for patients ≥ 12 years of age for these uses
- Administered IV over a period of one to 15 minutes with the rate adapted based on patient response (maximum infusion rate 2.5 mL/minute); can be administered by a caregiver following proper training by an HCP or at a hemophilia center; the initial dose for routine prophylaxis in children 7 to < 12 years of age is weight-based and given twice weekly with adjustments based on the patient’s clinical response and recovery; for other indications, consult Jivi product labeling; generally, dosage and duration are dependent on the severity of factor VIII deficiency, location and extend of bleeding, and patient’s clinical condition
May 21, 2025 – ranibizumab injection (Susvimo)
- Genentech; a vascular endothelial growth factor (VEGF) inhibitor
- New indication: for the treatment of patients with diabetic retinopathy who have previously responded to at least two intravitreal injections of a VEGF inhibitor
- Administered intravitreally as a continuously delivered dose via the Susvimo ocular implant with refills every 36 weeks (approximately nine months); supplemental treatment administered as an intravitreal ranibizumab injection can be administered in the affected eye if clinically required; the Susvimo ocular implant insertion, initial fill and implant removal procedures must be performed under aseptic conditions by a physician experienced in vitreoretinal surgery
- Other indications: patients who have previously responded to at least two intravitreal injections of a VEGF for either (1) neovascular (wet) age-related macular degeneration (AMD) or (2) diabetic macular edema (DME)
May 22, 2025 – mepolizumab (Nucala)
- GlaxoSmithKline; an IL-5 antagonist monoclonal antibody
- New indication: add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype
- Administered SC once every four weeks; a patient or caregiver may administer following HCP determination this is appropriate (must use the single-dose prefilled autoinjector or prefilled syringe; the vial requires reconstitution and administration by an HCP)
- Other indications: select patients with severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES)
Traditional
None
May 19, 2025 – COVID-19 Vaccine, Adjuvanted (Nuvaxovid)
- BLA approval; first recombinant protein-based, non-mRNA COVID-19 vaccine available in the U.S.; previously, this vaccine was available under emergency use authorization (EUA) for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals ≥ 12 years of age
- Indicated for (1) active immunization to prevent COVID-19 caused by SARS-CoV-2 in adults ≥ 65 years of age, and (2) for individuals 12 through 64 years of age who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g., asthma, cancer, diabetes, obesity, smoking)
- Injectable suspension: 0.5 mL in a prefilled syringe
- Recommended dosage is a single 0.5 mL dose administered intramuscularly (IM) by an HCP; for individuals previously vaccinated with any COVID-19 vaccine, administer the dose at least two months after the last dose of COVID-19 vaccine
- Product will be available from Novavax, in partnership with Sanofi, for the 2025–2026 COVID-19 vaccine formula in the fall of 2025
April 10, 2025 – metoprolol tartrate oral solution (Lopressor)
- 505(b)(2) NDA approval; first and only oral solution formulation of metoprolol
- Beta-adrenergic blocker
- Indicated for adults for (1) the treatment of hypertension, to lower blood pressure (lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular [CV] events, primarily strokes and myocardial infarctions [MI]), (2) the long-term treatment of angina pectoris and (3) the treatment of hemodynamically stable patients with definite or suspected MI, to reduce the risk of CV mortality when used in conjunction with IV metoprolol
- Oral solution: 10 mg/mL (equivalent to 3.9 mg metoprolol)
- Recommended starting dosage is taken orally in single or divided doses (hypertension) or is given as two divided doses (angina pectoris), titrated to an individualized maintenance dose; for MI, the starting dosage is dependent upon tolerance to IV metoprolol and is administered every six hours for 48 hours followed by titration (based on tolerability) to a twice daily maintenance dose; take the oral solution with or immediately following meals
- Product will be available from Validus with launch time frame TBD
April 15, 2025 – aripiprazole oral film (Mezofy)
- 505(b)(2) NDA approval; second aripiprazole oral dissolving film to receive FDA approval; the first is Opipza from Carwin which is supplied in the strengths of 2 mg, 5 mg and 10 mg (indicated for schizophrenia, major depressive disorder, irritability associated with autistic disorder, Tourette’s)
- Atypical antipsychotic
- Indicated for the treatment of schizophrenia in adult and pediatric patients ≥ 13 years of age
- Oral film: 5 mg, 10 mg and 15 mg
- Recommended dosage is administered once daily with or without food with dosing dependent on patient age (13 to 17 years of age versus adults); apply the oral film on top of the tongue allowing it to adhere and dissolve; do not chew the film; do not swallow undissolved Mezofy; wait until the film completely dissolves to swallow; the dissolved film can then be swallowed with or without water
- Boxed warning for increased mortality in elderly patients with dementia-related psychosis
- Product will be available from CMG with launch time frame TBD
April 30, 2025 – dihydroergotamine nasal powder (Atzumi)
- 505(b)(2) NDA approval; first dihydroergotamine (DHE) nasal powder for this indication (DHE is also available as a nasal spray solution)
- Ergotamine derivative
- Indicated for the acute treatment of migraine with or without aura in adults
- Limitations of use: not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura
- Nasal powder: 5.2 mg in a single-dose nasal device
- Recommended dosage is the contents of one nasal device administered as a powdered medicine into one nostril; if needed, the dose may be repeated a minimum of one hour after the first dose for a maximum of two doses per 24 hours; safety of taking more than four doses in seven days or 12 doses within a 30-day period has not been established
- Boxed warning for peripheral ischemia following coadministration with strong cytochrome P450 (CYP) 3A4 inhibitors
- Product will be available from Satsuma with launch time frame TBD
May 14, 2025 – dihydroergotamine injection (Brekiya)
- 505(b)(2) NDA approval; first DHE autoinjector for SC administration by the patient
- Ergotamine derivative
- Indicated for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults
- Limitations of use: not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura
- For injection: 1 mg/mL solution in a single-dose autoinjector
- Recommended dosage is administered SC into the skin of the middle thigh with a single autoinjector; dose may be repeated, as needed, at one-hour intervals to a total maximum of three doses in a 24-hour period and maximum of six doses per week; can be administered by the patient or a caregiver; the autoinjector takes about 10 seconds to deliver the dose
- Boxed warning for peripheral ischemia following coadministration with strong CYP 3A4 inhibitors
- Product will be available from Amneal in the second half of 2025
April 16, 2025 – palonosetron (Posfrea)
- Avyxa; serotonin-3 (5-HT3) receptor antagonist
- New indication: for pediatric patients one month to < 17 years of age for prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy (HEC); previously, only indicated for adults for select uses
- Administered as a single weight-based dose infused by an HCP over 15 minutes beginning approximately 30 minutes before the start of chemotherapy
April 17, 2025 – apixaban (Eliquis)
- Bristol-Myers Squibb; factor Xa inhibitor; new oral suspension formulation (Eliquis Sprinkle; Priority Review) (0.15 mg in a yellow opaque capsule) and new tablet for oral suspension (0.5 mg) approved in conjunction with new pediatric population indication; previously, only approved as oral tablets (2.5 mg, 5 mg)
- New indication: treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least five days of initial anticoagulant treatment
- Administered as a weight-based dose twice daily using the 0.15 mg powder in capsule for pediatric patients weighing 2.6 kg to < 4 kg and the 0.5 mg tablet for patients with body weight of 4 kg to < 35 kg (not recommended for use in pediatric patients with a body weight < 2.6 kg); the 2.5 mg and 5 mg tablets should be used for patients ≥ 35 kg
- Other indications: for adults (1) to reduce the risk of stroke and systemic embolism in nonvalvular atrial fibrillation, (2) for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), after hip or knee replacement surgery and (3) for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy
First generic drug launches
May 1, 2025 – ticagrelor (Brilinta)
- Watson launched a 60 mg generic to AstraZeneca’s Brilinta and Alkem Labs launched a 90 mg generic to AstraZeneca’s Brilinta
- P2Y₁₂ platelet inhibitor; indicated (1) to reduce the risk of CV death, MI and stroke in patients with acute coronary syndrome (ACS) or a history of MI (also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS), (2) to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events and (3) to reduce the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack (TIA)
- Recommended dosage is administered orally twice daily with dosing dependent on indication
- Annual sales for Brilinta 60 mg in 2024 were $251 million and $1,149 million for Brilinta 90 mg
May 6, 2025 – eslicarbazepine acetate (Aptiom)
- Alkem Labs launched a generic to Sumitomo’s Aptiom
- Voltage-gated sodium channel inhibitor; indicated for the treatment of partial-onset seizures in patients ≥ 4 years of age
- Recommended dosage is taken orally once daily with dosage dependent on age (pediatric versus adult) and body weight (pediatric only); the dose is increased in weekly intervals based on clinical response and tolerability to the recommended maintenance dosage
- Annual sales for Aptiom in 2024 were $408 million
May 8, 2025 – phentermine hydrochloride/topiramate (Qsymia)
- Teva/Actavis launched a generic to Vivus’ Qsymia
- Combination of phentermine, a sympathomimetic amine anorectic, and topiramate, an antiepileptic drug with weak carbonic anhydrase inhibitor activity; indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with a body mass index (BMI) of (1) ≥ 30 kg/m2 or (2) ≥ 27 kg/m² in the presence of at least one weight-related comorbidity (hypertension, type 2 diabetes mellitus or dyslipidemia)
- Recommended dosage is taken orally once daily in morning and titrated to the maximum dosage based on weight loss
- Annual sales for Qsymia in 2024 were $65 million
May 13, 2025 – tolvaptan (Jynarque)
- Lupin launched a generic to Otsuka’s Jynarque tablet
- Selective vasopressin V2-receptor antagonist; indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD)
- Recommended dosage is taken as an initial dose on waking and then a second lower dose eight hours later; minimum weekly interval for titration to the maximum dose, if tolerated; if needed, down-titrate for tolerability
- Annual sales for Jynarque in 2024 were $1,851 million
ANC absolute neutrophil count
ASAP as soon as possible
CBC complete blood count
COL7A1 collagen type VII alpha 1 chain
COVID-19 coronavirus disease 2019
DNA deoxyribonucleic acid
HSV-1 herpes-simplex virus type 1
KRAS Kirsten rat sarcoma viral oncogene homolog
mRNA messenger ribonucleic acid
PIK3CA phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha
WBC white blood cell
Editor-In-Chief: Maryam Tabatabai, PharmD
Executive Editor: Anna Schreck Bird, PharmD
Deputy Editors: Nicole Kjesbo, PharmD, BCPS; Olivia Pane, PharmD, CDCES
All brand names are property of their respective owners.