Clinical Highlights: March 2025 - Prime Therapeutics
Clinical Highlights: March 2025
Your monthly source for drug information highlights.
As of late February 2025, the United States (U.S.) Centers for Disease Control and Prevention (CDC) has been providing weekly updates on measles cases in the U.S. As of mid- to late March, 378 cases and three outbreaks (three or more related cases) have been reported in 2025. Most cases have occurred in pediatric individuals (< 5 years of age: 33%, 5 to 19 years of age: 42%) with 95% of the 378 cases being reported in persons who are unvaccinated or have an unknown vaccination status. Sixty-four individuals have required hospitalization, and two deaths have occurred (one from measles, one under investigation). Measles is an extremely infectious airborne virus that can lead to severe rash and complications, potentially including pneumonia, encephalitis and/or death due to respiratory or neurologic problems. It is especially dangerous for infants and children < 5 years of age as well as pregnant individuals, adults > 20 years of age and those with weakened immune systems. Symptoms usually occur seven to 14 days following infection and begin with high fever, cough, runny nose and conjunctivitis. Koplik spots (tiny white spots) can appear inside the mouth two to three days following the onset of symptoms, and the measles rash (maculopapular) occurs three to five days after the initial symptoms (typically begins on the face at the hairline and then spreads downward). Individuals who are infected are contagious from four days before the rash through four days afterward. The onset of rash from time of exposure is usually 10 to 14 days (range: seven to 21 days). No specific antiviral therapy is currently available for measles, and management primarily is supportive to alleviate symptoms and treat complications.
Vaccination with a measles, mumps and rubella (MMR) or a measles, mumps, rubella and varicella (MMRV) vaccine is highly effective at prevention of measles. One dose of the MMR vaccine is 93% effective at prevention of measles; two doses are 97% effective. The CDC recommends routine childhood vaccination with two doses of the MMR or MMRV vaccine with the first dose administered between age 12 to 15 months and the second dose given between age 4 and 6 years. In 2000, measles was eliminated in the U.S. due to high vaccination rates. However, global measles activity has increased and MMR coverage among kindergarteners is < 95% of the target. The CDC has issued a health advisory on the expanding measles outbreak in the U.S. which provides guidance on prevention and management. The advisory states the risk for widespread measles in the U.S. continues to be low due to immunization and surveillance programs but provides recommendations to health care professionals (HCPs) on who should receive vaccination and how to manage those suspected of having measles.
The CDC is reporting influenza-like illness (ILI) for the week ending March 15, 2025 (week 11). Seasonal influenza activity remains increased across the U.S. but has decreased for five consecutive weeks. Influenza A(H1N1)pdm09 and A(H3N2) continue to be the predominant viruses. As of March 13, 2025, the U.S. Food and Drug Administration (FDA) reports availability of antiviral influenza medications.
The FDA released a statement following the cancellation of the March 2025 Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on the influenza vaccine strains for the 2025 to 2026 influenza season in the U.S. The FDA continues to collaborate with federal and international partners as well as influenza vaccine manufacturers in anticipation of the upcoming influenza season, and convened a meeting with experts from the FDA, CDC and Department of Defense (DOD) to review epidemiologic and antigenic data related to currently circulating influenza viruses. Following the federal partner meeting, the FDA made recommendations to vaccine manufacturers for the virus strains for influenza vaccines for the 2025 to 2026 U.S. influenza season. The agency recommended that the trivalent formulation of egg-based influenza vaccines contain the following: (1) an A/Victoria/4897/2022 (H1N1)pdm09-like virus, (2) an A/Croatia/10136RV/2023 (H3N2)-like virus and (3) a B/Austria/1359417/2021 (B/Victoria lineage)-like virus. The trivalent formulation of cell- or recombinant-based influenza vaccines are recommended to contain (1) an A/Wisconsin/67/2022 (H1N1)pdm09-like virus, (2) an A/District of Columbia/27/2023 (H3N2)-like virus and (3) a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.
The World Health Organization (WHO) has announced their recommendations for influenza vaccine composition for the 2025 to 2026 northern hemisphere influenza season. Trivalent vaccines for the upcoming season that are egg-based are recommended to contain the same strains recommended by the FDA for egg-based influenza vaccines. For cell culture-, recombinant protein- or nucleic acid-based vaccines, recommended strains align with the FDA’s recommendations for cell- or recombinant-based influenza vaccines. For quadrivalent influenza vaccines, the B/Yamagata lineage component recommendation from WHO remains the same as previously recommended: a B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.
The CDC released a Morbidity and Mortality Weekly Report (MMWR) on interim estimates of vaccine effectiveness (VE) for the 2024 to 2025 seasonal influenza season from October 2024 to February 2025. VE was based on data from four CDC-affiliated VE networks. Estimated VE ranged from 32% to 60% among children and adolescents in outpatient settings (three networks) and was 63% to 78% against influenza-associated hospitalization (two networks). For adults, VE was 36% to 54% in the outpatient setting and 41% to 55% against influenza-associated hospitalization (two networks for both settings).
The CDC also published an MMWR reporting interim estimates of VE for the 2024 to 2025 coronavirus disease 2019 (COVID-19) vaccine in adults from September 2024 to January 2025. Compared with not receiving an updated COVID-19 vaccine dose, VE was estimated to be 33% against COVID-19–associated emergency department or urgent care visits in adults ≥ 18 years of age and 45% to 46% against hospitalizations among immunocompetent adults ≥ 65 years of age. In immunocompromised adults aged ≥ 65 years, VE against hospitalizations was 40%.
Shortage updates
The FDA provided a communication regarding the timeline by which state-licensed pharmacy/physician compounding and outsourcing facilities need to stop compounding glucagon-like peptide-1 agonists (GLP-1s), such as tirzepatide and semaglutide, as supply of these agents continues to stabilize. Novo Nordisk’s liraglutide (Saxenda) for weight management has limited availability, as does the liraglutide (Victoza) formulation indicated for select patients with type 2 diabetes mellitus (T2DM); an authorized generic of Victoza distributed by Teva is available.
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, as well as brand name Concerta from Janssen, are currently available. Methylphenidate ER film (Daytrana, generics) has limited availability or is 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; most 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.
The FDA is reporting bacitracin 3.5 g ophthalmic ointment from Padagis is unavailable due to discontinuation of the manufacture of the drug. The product is indicated for the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by bacitracin-susceptible organisms. Other generic versions of the ophthalmic ointment are also no longer commercially available; the shortage duration is unknown.
Drug information highlights
Sarepta, the manufacturer of delandistrogene moxeparvovec-rokl (Elevidys) has released a safety update on the adeno-associated virus vector-based gene therapy indicated for select patients with Duchenne muscular dystrophy (DMD). A young man with DMD has passed away following acute liver failure, after receiving Elevidys; a recent cytomegalovirus (CMV) infection has been identified as a possible contributing factor. Although acute liver injury is not a new safety finding and is described in the product labeling, acute liver failure resulting in death has not previously been reported in > 800 patients who have received the therapy either in clinical trials or in the post-marketing setting; Sarepta plans to update the product labeling as appropriate to reflect this event.
A forecasting study for the Global Burden of Disease Study 2021 has found that rates of overweight and obesity have increased globally, regionally and in all nations between 1990 and 2021, with an estimated one billion adult males and 1.1 billion adult females with overweight or obesity. The largest population of adults with overweight/obesity was in China, followed by India and the U.S. Based on historical trends, the study has forecasted an increase to 3.8 billion adults with overweight/obesity by 2050.
A forecasting study for the Global Burden of Disease Study 2021 has found that prevalence of child and adolescent overweight and obesity has doubled between 1990 and 2021. Furthermore, the prevalence of obesity alone during this time frame has tripled. By 2021, more than 93 million children between 5 to 14 years of age and greater than 80 million individuals 15 to 24 years of age had obesity with the highest prevalence in north Africa and the Middle East. Global increases in overweight prevalence are expected to stabilize from 2022 to 2050; however, the absolute proportion of the global population with obesity is predicted to increase substantially.
The FDA announced a limited number of voluntary recalls following internal testing demonstrating a small number of acne products containing benzoyl peroxide had possible benzene contamination. These voluntary recalls are to the retail level, and retailers should remove recalled products from shelves and online sale. Consumers are not instructed to act regarding these recalled products as the risk of developing cancer from daily use, for even decades, is very low. Affected products include select lots of (1) La Roche-Posay Effaclar Duo Dual Action Acne Treatment, (2) Walgreens Acne Control Cleanser, (3) Proactiv Emergency Blemish Relief Cream Benzoyl Peroxide 5%, (4) Proactiv Skin Smoothing Exfoliator, (5) SLMD Benzoyl Peroxide Acne Lotion and (6) Walgreens Tinted Acne Treatment Cream. In addition, the manufacturer of Zapzyt Acne Treatment Gel (10% benzoyl peroxide) is voluntarily recalling the product due to the elevated level of benzene found during its own testing.
As a precautionary measure, the FDA has announced voluntary withdrawal of certain lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) by the manufacturers following a higher rate of allergic/hypersensitivity type reactions, some of which were considered significant. In general, immune globulin products carry a risk for hypersensitivity and anaphylactic/anaphylactoid reactions. Certain lots of Xembify, Bivigam, Panzyga and Gamunex-C are included in the voluntary withdrawal.
The FDA has issued class-wide labeling changes for testosterone products based on results from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical study and required postmarketing ambulatory blood pressure (ABPM) studies. The TRAVERSE study showed there was not an increased risk of adverse cardiovascular (CV) outcomes in men using testosterone for hypogonadism, and the completed ABPM studies have demonstrated a class-wide increase in blood pressure with use of all testosterone products. Corresponding updates to product labeling for these agents are being recommended by the FDA.
Drug information happenings
Novo Nordisk has announced the launch of NovoCare Pharmacy, which will provide direct-to-patient home delivery of the GLP-1 receptor agonist semaglutide (Wegovy) at a cost of $499 per month. The offer is available for patients paying cash who are either uninsured or are eligible patients with commercial insurance; patients enrolled in any federal or state health care program with prescription drug coverage (e.g., Medicaid, Medicare, Medigap, Veterans Affairs [VA], DOD, TRICARE) are not eligible.
The Institute for Clinical and Economic Review (ICER) has released a Special Report on the Chronic Obstructive Pulmonary Disease (COPD) treatments fluticasone furoate/vilanterol (Breo Ellipta) and fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta). The report will be sent to Centers for Medicare & Medicaid Services (CMS) as a component of ICER’s contributions for Medicare drug price negotiations.
The American Academy of Pediatrics (AAP), American Academy of Family Physicians (AAFP), American College of Obstetricians and Gynecologists (ACOG) and American College of Physicians (ACP) have issued a statement regarding the National Institutes of Health (NIH) decision to terminate grants for studying vaccine hesitancy and uptake. The NIH has also announced plans for centralizing peer review for all applications for grants, cooperative agreements and research/development contracts within the agency’s Center for Scientific Review (CSR) in an effort to improve efficiency.
A joint clinical practice guideline on benzodiazepine tapering was developed and released by the American Society of Addiction Medicine (ASAM), the AAFP, the American Academy of Neurology (AAN), the American Academy of Physician Associates (AAPA), the American College of Medical Toxicology (ACMT), the American Association of Nurse Practitioners (AANP), the American Association of Psychiatric Pharmacists (AAPP), the American College of Obstetricians and Gynecologists (ACOG), the American Geriatrics Society (AGS) and the American Psychiatric Association (APA). Strategies for HCPs to determine whether benzodiazepine tapering may be appropriate and if so, how to taper are provided; the guideline is applicable to adults taking benzodiazepines regularly who may be at risk for physical dependence which is an expected outcome associated with use of these medications.
A synopsis of the Kidney Disease: Improving Global Outcomes (KDIGO) 2024 clinical practice guidelines on the evaluation, management and treatment of chronic kidney disease (CKD) in adults and children who are not receiving kidney replacement therapy has been published. The guidelines are comprised of 28 recommendations and 141 practice points (expert opinion); the focus of the synopsis is the recommendations with strongest evidence (level one or two) and includes practice points (ungraded) that have evolved since 2012.
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Executive Editor: Anna Schreck Bird, PharmD
Deputy Editor: Olivia Pane, PharmD, CDCES