Quarterly Drug Approvals: January 2025 - Prime Therapeutics
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Quarterly Drug Approvals: January 2025
This report provides an overview of new drugs and indications approved in 2024
January 31, 2025
Specialty drug approvals
Generic name | Brand name | Manufacturer | Indication(s) | Route of administration | Month approved* |
---|---|---|---|---|---|
concizumab-mtci | Alhemo | Novo Nordisk | Routine prophylaxis in hemophilia A or B with inhibitors (≥ 12 years of age) | SC | December |
crinecerfont | Crenessity | Neurocrine Biosciences | Congenital adrenal hyperplasia (≥ 4 years of age) | Oral | December |
olezarsen | Tryngolza | Ionis | Familial chylomicronemia syndrome | SC | December |
remestemcel-L-rknd | Ryoncil | Mesoblast | Steroid-refractory acute GVHD in pediatric patients (≥ 2 months of age) | IV | December |
vanzacaftor / tezacaftor / deutivacaftor | Alyftrek | Vertex | Cystic fibrosis with ≥ 1 F508del mutation or other responsive CFTR gene mutation (≥ 6 years of age) | Oral | December |
acoramidis | Attruby | BridgeBio | Cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) | Oral | November |
foscarbidopa / foslevodopa | Vyalev | Abbvie | Advanced Parkinson's disease | SC (continuous infusion) | October |
marstacimab-hncq | Hympavzi | Pfizer | Routine prophylaxis in hemophilia A or B without inhibitors (≥ 12 years of age) | SC | October |
arimoclomol | Miplyffa | Zevra | Niemann-Pick disease type C in combination with miglustat (≥ 2 years of age) | Oral | September |
lebrikizumab-lbkz | Ebglyss | Eli Lilly | Atopic dermatitis (≥ 12 years of age weighing ≥ 40 kg) | SC | September |
levacetylleucine | Aqneursa | IntraBio | Niemann-Pick disease type C (body weight ≥ 15 kg) | Oral | September |
ocrelizumab / hyaluronidase-ocsq | Ocrevus Zunovo | Genentech | Relapsing and progressive multiple sclerosis | SC | September |
octreotide acetate | Bynfezia Pen | Sun | (1) Acromegaly; (2) Carcinoid tumors; (3) Diarrhea associated with vasoactive intestinal peptide (VIP)-secreting tumors | SC | September |
axatilimab-csfr | Niktimvo | Incyte / Syndax | Chronic GVHD (body weight ≥ 40 kg) | IV | August |
nemolizumab-ilto | Nemluvio | Galderma | Prurigo nodularis | SC | August |
palopegteriparatide | Yorvipath | Ascendis | Hypoparathyroidism | SC | August |
seladelpar | Livdelzi | Gilead | Primary biliary cholangitis | Oral | August |
deuruxolitinib | Leqselvi | Sun | Severe alopecia areata | Oral | July |
donanemab-azbt | Kisunla | Eli Lilly | Early symptomatic Alzheimer's disease | IV | July |
paliperidone palmitate ER | Erzofri | Luye | (1) Schizophrenia; (2) Schizoaffective disorder | IM | July |
immune globulin intravenous, human-dira | Yimmugo | Grifols Biotest | Primary humoral immunodeficiency (≥ 2 years of age) | IV | June |
crovalimab-akkz | Piasky | Genentech | Paroxysmal nocturnal hemoglobinuria (≥ 13 years of age) | IV, SC | June |
elafibranor | Iqirvo | Ipsen | Primary biliary cholangitis | Oral | June |
ensifentrine | Ohtuvayre | Verona | Maintenance treatment of COPD | Oral inhalation | June |
imetelstat | Rytelo | Geron | Low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia | IV | June |
mavorixafor | Xolremdi | X4 Pharmaceuticals | Warts, hypogammaglobulinemia, infections, and myelokathexis (WHIM) syndrome | Oral | April |
danicopan | Voydeya | AstraZeneca | Paroxysmal nocturnal hemoglobinuria with extravascular hemolysis | Oral | March |
givinostat | Duvyzat | ITF | Duchenne muscular dystrophy | Oral | March |
macitentan / tadalafil | Opsynvi | Johnson and Johnson | Pulmonary arterial hypertension | Oral | March |
resmetirom | Rezdiffra | Madrigal | Noncirrhotic nonalcoholic steatohepatitis (NASH) | Oral | March |
sotatercept-csrk | Winrevair | Merck | Pulmonary arterial hypertension | SC | March |
vadadustat | Vafseo | Akebia | Anemia due to CKD (dialysis-dependent) | Oral | March |
Generic name | Brand name | Manufacturer | Indication(s) | Month approved* |
---|---|---|---|---|
antihemophilic factor, recombinant | Nuwiq | Octapharma | Expanded pediatric indication (< 2 years of age) for hemophilia A | December |
elexacaftor / tezacaftor / ivacaftor; ivacaftor | Trikafta | Vertex | Expanded indication for cystic fibrosis to include additional non-F508del CFTR gene mutations (≥ 2 years of age) | December |
hydroxyurea | Xromi | Rare Disease | Expanded indication to include patients ≥ 2 years of age for sickle cell anemia | December |
nemolizumab-ilto | Nemluvio | Galderma | Moderate to severe atopic dermatitis (≥ 12 years of age) | December |
setmelanotide | Imcivree | Rhythm | Expanded indication (≥ 2 years of age) for obesity due to Bardet-Biedl syndrome or POMC, PCSK1, or LEPR deficiency | December |
bimekizumab-bkzx | Bimzelx | UCB | Hidradenitis suppurativa | November |
methotrexate | Jylamvo | Shorla Oncology | Polyarticular juvenile idiopathic arthritis | October |
sodium oxybate | Lumryz | Avadel CNS | Expanded pediatric indication (≥ 7 years of age) for narcolepsy | October |
benralizumab | Fasenra | AstraZeneca | Eosinophilic granulomatosis with polyangiitis | September |
bimekizumab-bkzx | Bimzelx | UCB | (1) Psoriatic arthritis; (2) Ankylosing spondylitis; (3) Non-radiographic axial spondyloarthritis | September |
certolizumab pegol | Cimzia | UCB | Active polyarticular juvenile idiopathic arthritis (≥ 2 years of age) | September |
dupilumab | Dupixent | Regeneron | Expanded pediatric indication (≥ 12 years of age) for chronic rhinosinusitis with nasal polyps | September |
dupilumab | Dupixent | Regeneron | Uncontrolled COPD | September |
guselkumab | Tremfya | Janssen Biotech | Moderately to severely active ulcerative colitis | September |
lanreotide | no trade name | Cipla | Carcinoid syndrome | September |
anacaulase-bcdb | Nexobrid | Vericel | Expanded pediatric indication (all ages) for severe thermal burns | August |
iptacopan | Fabhalta | Novartis | Proteinuria reduction in primary immunoglobulin A nephropathy | August |
letermovir | Prevymis | Merck | Cytomegalovirus (CMV) prophylaxis in allogeneic HSCT (≥ 6 months of age weighing ≥ 6 kg) and high-risk kidney transplant (≥ 12 years of age weighing ≥ 40 kg) recipients | August |
cerliponase alfa | Brineura | Biomarin | Expanded pediatric indication (all ages) for neuronal ceroid lipofuscinosis type 2 (CLN2) | July |
fibrinogen (human) | Fibryga | Octapharma | Fibrinogen replacement in acquired fibrinogen deficiency | July |
immune globulin subcutaneous, human-klhw | Xembify | Grifols | Primary humoral immunodeficiency in treatment naïve patients (≥ 2 years of age) | July |
maralixibat | Livmarli | Mirum | Expanded pediatric indication (≥ 12 months of age) for progressive familial intrahepatic cholestasis | July |
peanut (Arachis hypogaea) allergen powder-dnfp | Palforzia | Stallergenes Greer | Expanded pediatric indication (≥ 1 year of age) for allergic reactions from peanut exposure in patients with peanut allergy | July |
efgartigimod alfa / hyaluronidase-qvfc | Vyvgart Hytrulo | Argenx | CIDP | June |
risankizumab-rzaa | Skyrizi | Abbvie | Moderately to severely active ulcerative colitis | June |
sarilumab | Kevzara | Sanofi | Active polyarticular juvenile idiopathic arthritis (body weight ≥ 63 kg) | June |
belimumab | Benlysta | GlaxoSmithKline | Expanded pediatric indication (≥ 5 years of age) for SC administration for systemic lupus erythematosus | May |
apremilast | Otezla | Amgen | Expanded pediatric indication (6 to 17 years of age, weighing ≥ 20 kg) for plaque psoriasis | April |
benralizumab | Fasenra | AstraZeneca | Expanded pediatric indication (6 to 11 years of age) for severe asthma | April |
vedolizumab | Entyvio | Takeda | Crohn's disease | April |
factor IX, recombinant | Ixinity | Medexus | Expanded pediatric indication (< 12 years of age) for hemophilia B | March |
maralixibat | Livmarli | Mirum | Expanded pediatric indication (≥ 5 years of age) for cholestatic pruritus with progressive familial intrahepatic cholestasis (PFIC) | March |
ravulizumab-cwvz | Ultomiris | Alexion | Neuromyelitis optica spectrum disorder (AQP4 antibody-positive) | March |
spesolimab-sbzo | Spevigo | Boeringer Ingelheim | Generalized pustular psoriasis | March |
bictegravir / emtricitabine / tenofovir alafenamide | Biktarvy | Gilead | Expanded indication for HIV-1 infection with M184V/I resistance | February |
omalizumab | Xolair | Genentech / Novartis | Reduction of allergic reactions that may occur with an accidental exposure to one or more foods | February |
dupilumab | Dupixent | Sanofi / Regeneron | Expanded pediatric indication (≥ 1 year of age) for eosinophilic esophagitis | January |
immune globulin infusion (human) | Gammagard Liquid | Takeda | CIDP | January |
immune globulin infusion 10% (human) / recombinant human hyaluronidase | HyQvia | Takeda | CIDP | January |
Generic name | Brand name | Manufacturer | Indication(s) | Route of administration | Month approved* |
---|---|---|---|---|---|
cosibelimab-ipdl | Unloxcyt | Checkpoint | Metastatic or locally advanced cutaneous squamous cell carcinoma | IV | December |
ensartinib | Ensacove | Xcovery | ALK+ locally advanced or metastatic NSCLC | Oral | December |
nivolumab / hyaluronidase-nvhy | Opdivo Qvantig | Bristol-Myers Squibb | Most indications of Opdivo | SC | December |
zenocutuzumab-zbco | Bizengri | Merus | (1) NRG1+ NSCLC; (2) NRG1+ pancreatic adenocarcinoma | IV | December |
imatinib oral solution | Imkeldi | Shorla Oncology | Certain types of CML, ALL, and other cancers | Oral | November |
nilotinib | Danziten | Azurity | (1) Newly diagnosed Ph+ CML in chronic phase; (2) Chronic phase and accelerated phase Ph+ CML resistant to prior therapy | Oral | November |
revumenib | Revuforj | Syndax | R/R acute leukemia with KMT2A translocation (≥ 1 year of age) | Oral | November |
zanidatamab-hrii | Ziihera | Jazz | Previously treated unresectable or metastatic HER2+ (IHC 3+) biliary tract cancer | IV | November |
inavolisib | Itovebi | Genentech | Endocrine-resistant, PIK3CA-mutated, HR+, HER2- advanced breast cancer in combination with palbociclib and fulvestrant | Oral | October |
zolbetuximab-clzb | Vyloy | Astellas | Advanced HER2- gastric or gastroesophageal junction adenocarcinoma in combination with chemotherapy | IV | October |
atezolizumab / hyaluronidase-tqjs | Tecentriq Hybreza | Genentech | All IV indications of Tecentriq (e.g., select adults with NSCLC, SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma) | SC | September |
bortezomib | no trade name | Shilpa Medicare Limited | (1) Multiple myeloma; (2) Mantle cell lymphoma | IV, SC | August |
denileukin diftitox-cxdl | Lymphir | Citius | R/R cutaneous T-cell lymphoma | IV | August |
lazertinib | Lazcluze | Janssen | First-line treatment of EGFR-mutated NSCLC in combination with amivantamab | Oral | August |
vorasidenib | Voranigo | Servier | Grade 2 IDH-mutant astrocytoma or oligodendroglioma (≥ 12 years of age) | Oral | August |
thiotepa | Tepylute | Shorla | Adenocarcinoma of the breast or ovary | IV | June |
tarlatamab-dlle | Imdelltra | Amgen | Extensive-stage SCLC with progression on or after platinum-based chemotherapy | IV | May |
nogapendekin alfa inbakicept-pmln | Anktiva | ImmunityBio | In combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS) | Intravesically | April |
tovorafenib | Ojemda | Day One | R/R pediatric low-grade glioma with BRAF fusion or rearrangement or BRAF V600 mutation (≥ 6 months of age) | Oral | April |
tislelizumab-jsgr | Tevimbra | BeiGene | Esophageal squamous cell carcinoma | IV | March |
Generic name | Brand name | Manufacturer | Indication(s) | Month approved* |
---|---|---|---|---|
durvalumab | Imfinzi | AstraZeneca | Limited-stage SCLC | December |
encorafenib | Braftovi | Array | BRAF V600E-mutant metastatic colorectal cancer in combination with cetuximab and mFOLFOX6 | December |
tislelizumab-jsgr | Tevimbra | Beigene | Unresectable or metastatic HER2-, PD-L1+ gastric or gastroesophageal junction adenocarcinoma in combination with chemotherapy | December |
asciminib | Scemblix | Novartis | Newly diagnosed Ph+ CML in chronic phase | October |
nivolumab | Opdivo | Bristol-Myers Squibb | Neoadjuvant and adjuvant treatment of resectable NSCLC | October |
amivantamab-vmjw | Rybrevant | Janssen | Locally advanced or metastatic EGFR-mutated NSCLC in combination with carboplatin and pemetrexed | September |
isatuximab-irfc | Sarclisa | Sanofi-Aventis | Newly diagnosed, transplant-ineligible multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone | September |
osimertinib | Tagrisso | AstraZeneca | Unresectable, stage III, EGFR-mutated NSCLC | September |
pembrolizumab | Keytruda | Merck | First-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma in combination with pemetrexed and platinum chemotherapy | September |
ribociclib | Kisqali | Novartis | HR+, HER2- stage II and III early breast cancer in combination with an aromatase inhibitor | September |
amivantamab-vmjw | Rybrevant | Janssen | First-line treatment of EGFR-mutated NSCLC in combination with lazertinib | August |
dostarlimab-gxly | Jemperli | GlaxoSmithKline | All adults with primary advanced or recurrent endometrial cancer in combination with carboplatin and paclitaxel | August |
durvalumab | Imfinzi | AstraZeneca | Resectable early-stage NSCLC as neoadjuvant and adjuvant treatment before and after surgery | August |
daratumumab / hyaluronidase-fihj | Darzalex Faspro | Janssen | Newly diagnosed, transplant-eligible multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone | July |
ribociclib | Kisqali | Novartis | All adults with HR+, HER2- advanced or metastatic breast cancer in combination with fulvestrant | June |
adagrasib | Krazati | Mirati | KRAS G12C-mutated locally advanced or metastatic colorectal cancer in combination with cetuximab | June |
blinatumomab | Blincyto | Amgen | CD19+ Ph- B-cell precursor ALL in the consolidation phase of multiphase chemotherapy (≥ 1 month of age) | June |
durvalumab | Imfinzi | AstraZeneca | Primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) | June |
epcoritamab-bysp | Epkinly | Genmab | R/R follicular lymphoma following ≥ 2 prior lines of therapy | June |
pembrolizumab | Keytruda | Merck | Primary advanced or recurrent endometrial carcinoma | June |
repotrectinib | Augtyro | Bristol-Myers Squibb | Solid tumors that: (1) have an NTRK gene fusion, (2) are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and (3) have progressed following treatment or have no satisfactory alternative therapy (≥ 12 years of age) | June |
selpercatinib | Retevmo | Eli Lilly | Expanded pediatric indication (2 years to and 12 years of age) for: (1) advanced or metastatic medullary thyroid cancer with RET mutation, (2) advanced or metastatic thyroid cancer with RET gene fusion, and (3) locally advanced or metastatic solid tumors with RET gene fusion | May |
alectinib | Alecensa | Genentech | Adjuvant therapy of NSCLC that is ALK+ (tumors ≥ 4 cm or node positive) | April |
fam-trastuzumab deruxtecan-nxki | Enhertu | Daiichi Sankyo | Unresectable or metastatic HER2+ solid tumors as second-line or later therapy | April |
inotuzumab ozogamicin | Besponsa | Pfizer | R/R CD22+ B-cell precursor ALL (pediatric patients ≥ 1 year of age) | March |
nivolumab | Opdivo | Bristol-Myers Squibb | Unresectable or metastatic urothelial carcinoma as first-line in combination with cisplatin and gemcitabine chemotherapy | March |
ponatinib | Iclusig | Takeda | Newly diagnosed Ph+ ALL as first-line treatment | March |
zanubrutinib | Brukinsa | BeiGene | In combination with obinutuzumab for treatment of adults with R/R follicular lymphoma after ≥ 2 prior lines of systemic therapy | March |
irinotecan liposome | Onivyde | Ipsen | Metastatic pancreatic ductal adenocarcinoma as first-line treatment | February |
osimertinib | Tagrisso | AstraZeneca | Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, for use in combination with pemetrexed and platinum chemotherapy (first-line) | February |
alpelisib | Piqray | Novartis | In combination with fulvestrant for treatment of pre- and perimenopausal women with HR+, HER2-, PIK3CA-mutated, advanced or metastatic breast cancer | January |
pembrolizumab | Keytruda | Merck | In combination with chemoradiotherapy for newly diagnosed patients with advanced cervical cancer | January |
erdafitinib | Balversa | Janssen | Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations who progressed on or after ≥ 1 line of systemic therapy | January |
Traditional drug approvals
Generic name | Brand name | Manufacturer | Indication(s) | Route of administration | Month approved* |
---|---|---|---|---|---|
tizanidine oral solution | Ontralfy | Fidelity | Spasticity | Oral | December |
minocycline hydrochloride ER capsule | Emrosi | Journey | Inflammatory lesions of rosacea | Oral | November |
sulopenem etzadroxil / probenecid | Orlynvah | Iterum | Uncomplicated UTI in women with limited or no alternative oral treatment options | Oral | October |
xanomeline / trospium chloride | Cobenfy | Bristol-Myers Squibb | Schizophrenia | Oral | September |
carbidopa / levodopa ER | Crexont | Amneal | Parkinson's disease | Oral | August |
epinephrine nasal spray | Neffy | ARS | Allergic reactions including anaphylaxis (patients weighing ≥ 30 kg) | Intranasal | August |
nalmefene injection | Zurnai | Purdue | Opioid overdose (≥ 12 years of age) | IM, SC | August |
benzgalantamine delayed-release | Zunveyl | Alpha Cognition | Alzheimer's disease | Oral | July |
norethindrone acetate / ethinyl estradiol ODT | Femlyv | Millicent | Pregnancy prevention (females of reproductive potential) | Oral | July |
sitagliptin / metformin hydrochloride ER | Zituvimet XR | Zydus | T2DM | Oral | July |
terazosin oral solution | Tezruly | Ani | (1) BPH; (2) Hypertension | Oral | July |
sofpironium | Sofdra | Botanix | Primary axillary hyperhidrosis (≥ 9 years of age) | Topical | June |
tadalafil | Chewtadzy | Ani | (1) Erectile dysfunction (ED); (2) Signs and symptoms of BPH; (3) ED and the signs and symptoms of BPH | Oral | June |
vigabatrin | Vigafyde | Pyros | Infantile spasms for whom the potential benefits outweigh the potential risk of vision loss (patients 1 month to 2 years of age) (monotherapy) | Oral | June |
clonidine | Onyda XR | Tris | ADHD (pediatric patients ≥ 6 years of age) | Oral | May |
mycophenolate mofetil oral suspension | Myhibbin | Azurity | Organ rejection prophylaxis (≥ 3 months of age) | Oral | May |
ceftobiprole medocaril | Zevtera | Basilea | (1) Staphylococcus aureus bacteremia (adults); (2) Acute bacterial skin and skin structure infections (adults); (3) Community-acquired bacterial pneumonia (ages ≥ 3 months) | IV | April |
diazepam buccal film | Libervant | Aquestive | Acute treatment of intermittent, stereotypic episodes of frequent seizure activity distinct from a patient’s usual seizure pattern (2 to 5 years of age) | Oral transmucosal | April |
naloxone (high-dose) | Rezenopy | Summit | Opioid overdose | Intranasal | April |
pivmecillinam | Pivya | Utility Therapeutics | Uncomplicated UTI in adult females | Oral | April |
valbenazine | Ingrezza Sprinkle | Neurocrine Biosciences | Huntington’s disease-associated tardive dyskinesia and chorea | Oral | April |
aprocitentan | Tryvio | Idosia | Difficult-to-control or resistant hypertension | Oral | March |
risperidone ER injection | Risvan | Laboratorios Farmacéuticos Rovi | Schizophrenia | IM | March |
budesonide | Eohilia | Takeda | Inflammation caused by eosinophilic esophagitis | Oral | February |
cefepime / enmetazobactam | Exblifep | Allecra | Complicated UTI | IV | February |
iloprost | Aurlumyn | Eicos Science / Actelion | Severe frostbite | IV | February |
berdazimer | Zelsuvmi | Ligand | Molluscum contagiosum | Topical | January |
Generic name | Brand name | Manufacturer | Indication(s) | Month approved* |
---|---|---|---|---|
canagliflozin; canagliflozin / metformin | Invokana; Invokamet; Invokamet XR | Janssen | Expanded indication (≥ 10 years of age) for T2DM | December |
dapagliflozin / metformin ER | Xigduo XR | AstraZeneca | Reduce risk of CV death and hospitalization for HF in adults with T2DM and HF (dapagliflozin component only) | December |
fondaparinux | Arixtra | Mylan | Treatment of VTE in pediatric patients (age ≥ 1 year and weight ≥ 10 kg) | December |
tapinarof | Vtama | Dermavant | Atopic dermatitis (≥ 2 years of age) | December |
tirzepatide | Zepbound | Eli Lilly | Moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity | December |
vibegron | Gemtesa | Sumitomo | Overactive bladder in males with BPH | December |
dalteparin sodium | Fragmin | Pfizer | Expanded pediatric indication (birth to and 1 month of age) for symptomatic VTE | October |
roflumilast cream 0.15% | Zoryve | Arcutis | Expanded pediatric indication (≥ 6 years of age) for atopic dermatitis | July |
sucroferric oxyhydroxide | Velphoro | Fresenius | Expanded pediatric indication (≥ 9 years of age) for hyperphosphatemia in CKD on dialysis | July |
vonoprazan | Voquezna | Phathom | Heartburn associated with non-erosive GERD | July |
dapagliflozin | Farxiga | AstraZeneca | Expanded pediatric indication (≥ 10 years of age) for T2DM | June |
dapagliflozin / metformin ER | Xigduo XR | AstraZeneca | Expanded pediatric indication (≥ 10 years of age) for T2DM | June |
lacosamide ER | Motpoly XR | Aucta | Adjunctive therapy for primary generalized tonic-clonic seizures (adults and pediatric patients weighing ≥ 50 kg) | June |
pitolisant | Wakix | Harmony | Narcolepsy (≥ 6 years of age) | June |
dolutegravir / lamivudine | Dovato | Viiv | Expanded pediatric indication (≥ 12 years of age, weighing ≥ 25 kg) for treatment of HIV-1 infection | April |
dolutegravir / lamivudine | Dovato | Viiv | Expanded pediatric indication (≥ 12 years of age, weighing ≥ 25 kg) for treatment of HIV-1 infection | April |
iloperidone | Fanapt | Vanda | Acute treatment of manic or mixed episodes in adults with bipolar I disorder | April |
alirocumab | Praluent | Regeneron | Expanded pediatric indication (≥ 8 years of age) for heterozygous familial hypercholesterolemia | March |
baloxavir marboxil tablet and granules for oral suspension | Xofluza | Genentech | Expanded pediatric indication (5 to < 12 years of age) for influenza | March |
bempedoic acid | Nexletol | Esperion | Reduce the risk of MI and coronary revascularization in adults unable to take recommended statin therapy at high risk or with established CVD | March |
bempedoic acid / ezetimibe | Nexlizet | Esperion | Reduce the risk of MI and coronary revascularization in adults unable to take recommended statin therapy, at high risk or with established CVD | March |
fluticasone propionate | Xhance | Optinose | Chronic sinusitis including patients without polyps in the nasal cavity | March |
rilpivirine | Edurant; Edurant PED | Janssen | Expanded pediatric indication (2 to 12 years of age, weighing ≥ 25 kg to and 35 kg, treatment-naïve with HIV-1 RNA ≤ 100,000 copies/mL) for HIV-1 infection | March |
semaglutide | Wegovy | Novo Nordisk | Higher dose than used in diabetes approved for risk reduction of major adverse events (CV death, non-fatal MI, non-fatal stroke) in adults with established CVD and obesity or overweight | March |
tenofovir alafenamide | Vemlidy | Gilead | Expanded pediatric indication (6 to < 12 years of age, weighing ≥ 25 kg) for chronic hepatitis B virus infection | March |
remdesivir | Veklury | Gilead | Expanded pediatric indication (from birth) for COVID-19 | February |
ceftazidime / avibactam | Avycaz | AbbVie | Expanded pediatric indication (birth to < 3 months of age) for certain bacterial infections | January |
Generic name | Brand name | Manufacturer | Indication(s) | Route of administration | Month approved* |
---|---|---|---|---|---|
smallpox and mpox (vaccinia) vaccine, live | ACAM2000 | Emergent | Mpox disease prevention in high-risk patients | Percutaneous | August |
pneumococcal 21-valent conjugate vaccine | Capvaxive | Merck | Active immunization for the prevention of invasive disease caused by certain Streptococcus pneumoniae (ages ≥ 18 years); active immunization for the prevention of pneumonia caused by S. pneumoniae certain serotypes (ages ≥ 18 years) | IM | June |
respiratory syncytial virus vaccine | mRESVIA | Moderna | Prevention of RSV-related LRTD in individuals ≥ 60 years of age | IM | May |
Generic name | Brand name | Manufacturer | Indication(s) | Route of administration | Month approved* |
---|---|---|---|---|---|
respiratory syncytial virus vaccine | Abrysvo | Pfizer | Expanded indication (18 to 59 years of age with increased risk) for prevention of LRTD caused by RSV | IM | October |
RSV vaccine, adjuvanted | Arexvy | GlaxoSmithKline | Expanded indication (50 to 59 years of age) for the prevention of RSV-associated LRTD who are at an increased risk for the condition | IM | June |
Gene and cellular therapy and biosimilar approvals
Generic name | Brand name | Reference product | Manufacturer | Indication(s) | Route of administration | Month approved* |
---|---|---|---|---|---|---|
ustekinumab-stba | Steqeyma | Stelara | Celltrion | Autoimmune disorders | IV, SC | December |
ustekinumab-kfce | Yesintek | Stelara | Biocon | Autoimmune disorders | IV, SC | November |
ustekinumab-srlf | Imuldosa | Stelara | Accord | Autoimmune disorders | IV, SC | October |
ustekinumab-aauz | Otulfi | Stelara | Fresenius Kabi | Autoimmune disorders | IV, SC | September |
aflibercept-abzv | Enzeevu (provisionally interchangeable) | Eylea | Sandoz | Macular and retinal disorders | Intravitreal | August |
aflibercept-ayyh | Pavblu (provisionally interchangeable) | Eylea | Amgen | Macular and retinal disorders | Intravitreal | August |
eculizumab-aagh | Epysqli | Soliris | Samsung Bioepis | (1) Paroxysmal nocturnal hemoglobinuria; (2) Atypical hemolytic uremic syndrome | IV | July |
aflibercept-mrbb | Ahzantive | Eylea | Formycon | Macular and retinal disorders | Intravitreal | June |
filgrastim-txid | Nypozi | Neupogen | Tanvex | Neutropenia; Stem cell mobilization | IV, SC | June |
ustekinumab-ttwe | Pyzchiva (provisionally interchangeable) | Stelara | Sandoz / Samsung Bioepis | Autoimmune disorders | IV, SC | June |
aflibercept-jbvf | Yesafili | Eylea | Biocon | Macular and retinal disorders | Intravitreal | May |
aflibercept-yszy | Opuviz | Eylea | Samsung Bioepis / Biogen | Macular and retinal disorders | Intravitreal | May |
eculizumab-aeeb | Bkemv (interchangeable) | Soliris | Amgen | (1) Paroxysmal nocturnal hemoglobinuria; (2) Atypical hemolytic uremic syndrome | IV | May |
trastuzumab-strf | Hercessi | Herceptin | Accord | Breast cancer (HER2+); Gastric cancer (HER2+) | IV | April |
ustekinumab-aekn | Selarsdi | Stelara | Alvotech / Teva | Autoimmune disorders | SC | April |
denosumab-bbdz | Jubbonti (interchangeable) | Prolia | Sandoz | Bone health | SC | March |
denosumab-bbdz | Wyost | Xgeva | Sandoz | Bone health | SC | March |
tocilizumab-aazg | Tyenne | Actemra | Fresenius Kabi | Autoimmune disorders | IV, SC | March |
adalimumab-ryvk | Simlandi (interchangeable of high concentration [100 mg/mL citrate-free]) | Humira | Alvotech / Teva | Autoimmune disorders | SC | February |
Generic name | Brand name | Manufacturer | Indication(s) | Month approved* |
---|---|---|---|---|
eculizumab-aagh | Epysqli | Samsung Bioepis | AchR-positive generalized myasthenia gravis | November |
eculizumab-aeeb | Bkemv | Amgen | AchR-positive generalized myasthenia gravis | October |
filgrastim-sndz | Zarxio | Sandoz | Hematopoietic syndrome of acute radiation syndrome | October |
ustekinumab-aekn | Selarsdi | Teva | (1) Crohn's disease; (2) Ulcerative colitis | October |
tocilizumab-bavi | Tofidence | Biogen | (1) Giant cell arteritis; (2) Hospitalized adults with COVID-19 | July |
adalimumab-adbm (100 mg/mL) (new formulation) | Cyltezo | Boehringer Ingelheim | Autoimmune disorders | April |
pegfilgrastim-bmez | Ziextenzo | Sandoz | Hematopoietic subsyndrome of acute radiation syndrome | February |
Generic name | Brand name | Manufacturer | Indication(s) | Route of administration | Month approved* |
---|---|---|---|---|---|
eladocagene exuparvovec-tneq | Kebilidi | PTC | Aromatic L-amino acid decarboxylase (AADC) deficiency | Intraputaminal | November |
obecabtagene autoleucel | Aucatzyl | Autolus | Relapsed or refractory B-cell precursor ALL | IV | November |
afamitresgene autoleucel | Tecelra | Adaptimmune | Unresectable or metastatic synovial sarcoma | IV | August |
fidanacogene elaparvovec-dzkt | Beqvez | Pfizer | Hemophilia B without AAVRh74var capsid neutralizing antibodies | IV | April |
atidarsagene autotemcel | Lenmeldy | Orchard | Early-onset metachromatic leukodystrophy | IV | March |
lifileucel | Amtagvi | Iovance | Unresectable or metastatic melanoma | IV | February |
Generic name | Brand name | Manufacturer | Indication(s) | Month approved* |
---|---|---|---|---|
delandistrogene moxeparvovec-rokl | Elevidys | Sarepta | Expanded indication to include ambulatory patients ≥ 4 years of age (full approval) and non-ambulatory patients ≥ 4 years of age (Accelerated Approval) with Duchenne muscular dystrophy with a confirmed DMD gene mutation | June |
lisocabtagene maraleucel | Breyanzi | Bristol-Myer Squibb | (1) R/R mantle cell lymphoma following ≥ 2 prior lines of systemic therapy; (2) R/R follicular lymphoma following ≥ 2 prior lines of systemic therapy | May |
ciltacabtagene autotemcel | Carvykti | Janssen | R/R multiple myeloma following ≥ 1 prior line of therapy | April |
idecabtagene vicleucel | Abecma | Bristol-Myer Squibb | R/R multiple myeloma following ≥ 2 prior lines of therapy | April |
lisocabtagene maraleucel | Breyanzi | Bristol-Myer Squibb | R/R chronic lymphocytic or small lymphocytic lymphoma following ≥ 2 prior lines of therapy | March |
exagamglogene autotemcel | Casgevy | Vertex / CRISPR | Transfusion-dependent beta-thalassemia | January |
AAVRh74var adeno-associated virus serotype Rh74var
AchR acetylcholine receptor
ADHD attention deficit hyperactivity disorder
ALK anaplastic lymphoma kinase
ALK+ anaplastic lymphoma kinase-positive
ALL acute lymphoblastic leukemia
AQP4 anti-aquaporin-4
BPH benign prostatic hyperplasia
BRAF v-raf murine sarcoma viral oncogene homolog B1
CD19+ cluster of differentiate 19-positive
CD22+ cluster of differentiate 22-positive
CFTR cystic fibrosis transmembrane conductance regulator
CIDP chronic inflammatory demyelinating polyneuropathy
CKD chronic kidney disease
CML chronic myeloid leukemia
COPD chronic obstructive pulmonary disease
COVID-19 coronavirus disease 2019
CV cardiovascular
CVD cardiovascular disease
DMD Duchenne muscular dystrophy
EGFR epidermal growth factor receptor
ER extended release
FGFR3 fibroblast growth factor receptor 3
GERD gastroesophageal reflux disease
GVHD graft versus host disease
HER2 human epidermal growth factor receptor 2
HER2+ human epidermal growth factor receptor 2-positive
HER2- human epidermal growth factor receptor 2-negative
HF heart failure
HIV-1 human immunodeficiency virus type-1
HR hormone receptor
HR+ hormone receptor-positive
HSCT hematopoietic stem cell transplant
IDH isocitrate dehydrogenase
IHC3+ immunohistochemistry 3-positive
IM intramuscular
IV intravenous
KMT2A lysine methyltransferase 2A gene
KRAS Kirsten rat sarcoma virus
LEPR leptin receptor
LRTD lower respiratory tract disease
mFOLFOX6 fluorouracil, leucovorin, oxaliplatin
MI myocardial infarction
NRG1+ neuregulin 1-positive
NSCLC non-small cell lung cancer
NTRK neurotrophic tyrosine receptor kinase
ODT orally disintegrating tablet
PCSK1 proprotein convertase subtilisin/kexin type 1
PD-L1+ programmed death-ligand 1-positive
Ph+ Philadelphia chromosome-positive
Ph- Philadelphia chromosome-negative
PIK3CA phosphatidylinositol-3-kinase catalytic subunit alpha
POMC pro-opiomelanocortin
R/R relapsed or refractory
RET rearranged during transfection
RNA ribonucleic acid
RSV respiratory syncytial virus
SC subcutaneous
SCLC small cell lung cancer
T2DM type 2 diabetes mellitus
UTI urinary tract infection
VTE venous thromboembolism
XR extended release
AchR acetylcholine receptor
ADHD attention deficit hyperactivity disorder
ALK anaplastic lymphoma kinase
ALK+ anaplastic lymphoma kinase-positive
ALL acute lymphoblastic leukemia
AQP4 anti-aquaporin-4
BPH benign prostatic hyperplasia
BRAF v-raf murine sarcoma viral oncogene homolog B1
CD19+ cluster of differentiate 19-positive
CD22+ cluster of differentiate 22-positive
CFTR cystic fibrosis transmembrane conductance regulator
CIDP chronic inflammatory demyelinating polyneuropathy
CKD chronic kidney disease
CML chronic myeloid leukemia
COPD chronic obstructive pulmonary disease
COVID-19 coronavirus disease 2019
CV cardiovascular
CVD cardiovascular disease
DMD Duchenne muscular dystrophy
EGFR epidermal growth factor receptor
ER extended release
FGFR3 fibroblast growth factor receptor 3
GERD gastroesophageal reflux disease
GVHD graft versus host disease
HER2 human epidermal growth factor receptor 2
HER2+ human epidermal growth factor receptor 2-positive
HER2- human epidermal growth factor receptor 2-negative
HF heart failure
HIV-1 human immunodeficiency virus type-1
HR hormone receptor
HR+ hormone receptor-positive
HSCT hematopoietic stem cell transplant
IDH isocitrate dehydrogenase
IHC3+ immunohistochemistry 3-positive
IM intramuscular
IV intravenous
KMT2A lysine methyltransferase 2A gene
KRAS Kirsten rat sarcoma virus
LEPR leptin receptor
LRTD lower respiratory tract disease
mFOLFOX6 fluorouracil, leucovorin, oxaliplatin
MI myocardial infarction
NRG1+ neuregulin 1-positive
NSCLC non-small cell lung cancer
NTRK neurotrophic tyrosine receptor kinase
ODT orally disintegrating tablet
PCSK1 proprotein convertase subtilisin/kexin type 1
PD-L1+ programmed death-ligand 1-positive
Ph+ Philadelphia chromosome-positive
Ph- Philadelphia chromosome-negative
PIK3CA phosphatidylinositol-3-kinase catalytic subunit alpha
POMC pro-opiomelanocortin
R/R relapsed or refractory
RET rearranged during transfection
RNA ribonucleic acid
RSV respiratory syncytial virus
SC subcutaneous
SCLC small cell lung cancer
T2DM type 2 diabetes mellitus
UTI urinary tract infection
VTE venous thromboembolism
XR extended release
*Disclaimer: Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer.
All brand names are property of their respective owners.