Perspectives
Drug Approvals Quarterly Update: April 2024
April 25, 2024This wrap-up provides a review of newly approved drugs, recent drug launches, new indications and news of note on drugs in the approval process.
Traditional drug approvals
Traditional drug approvals – 2024
| Generic Name | Brand Name | Manufacturer | Indication(s) | Route of Administration | Month Approved* |
| aprocitentan | Tryvio® | Idosia | Difficult-to-control or resistant hypertension | Oral | March |
| budesonide | Eohilia™ | Takeda | Inflammation caused by eosinophilic esophagitis | Oral | February |
| iloprost | Aurlumyn™ | Eicos Science and Actelion | Severe frostbite | Intravenous (IV) | February |
| cefepime/ enmetazobactam |
Exblifep® | Allecra | Complicated urinary tract infections | IV | February |
| letibotulinumtoxinA-wlbg | Letybo® | Hugel America | Glabellar lines | Intramuscular (IM) | February |
| berdazimer | Zelsuvmi™ | Ligand | Molluscum contagiosum | Topical | January |
*Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer.
New indications for approved traditional drugs – 2024
| Generic Name | Brand Name | Manufacturer | Indication | Month Approved |
| baloxavir marboxil | Xofluza® | Genentech | Expanded pediatric indication (5 to < 12 years of age) for the tablet and granules for oral suspension formulations for influenza | March |
| semaglutide | Wegovy® | Novo Nordisk | Higher dose than used in diabetes approved for risk reduction of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with established CV disease and obesity or overweight | March |
| alirocumab | Praluent® | Regeneron | Expanded pediatric indication (> 8 years of age) for heterozygous familial hypercholesterolemia | March |
| fluticasone propionate | Xhance® | Optinose | Chronic sinusitis including patients without polyps in the nasal cavity | 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 |
Vaccine and immunization new approvals – 2024
| Generic Name | Brand Name | Brand Manufacturer | Indication | Month Approved |
| None |
Specialty drug approvals
Specialty drug approvals – 2024
| Generic Name | Brand Name | Manufacturer | Indication(s) | Route of Administration | Month Approved |
| givinostat | Duvyzat™ | ITF | Duchenne muscular dystrophy (DMD) | Oral | March |
| resmetirom | Rezdiffra™ | Madrigal | Noncirrhotic nonalcoholic steatohepatitis (NASH) | Oral | March |
| macitentan/tadalafil | Opsynvi | Johnson and Johnson | Pulmonary arterial hypertension (PAH) | Oral | March |
| sotatercept-csrk | Winrevair™ | Merck | PAH | SC | March |
| vadadustat | Vafseo® | Akebia | Anemia due to chronic kidney disease (CKD) dialysis-dependent | Oral | March |
| danicopan | Voydeya™ | AstraZeneca | Paroxysmal nocturnal hemoglobinuria with extravascular hemolysis | Oral | March |
New indications for approved specialty drugs -2024
| Generic Name | Brand Name | Manufacturer | New Indication(s) | Month Approved |
| dupilumab | Dupixent® | Sanofi/Regeneron | Expanded pediatric indication (>1 year) for eosinophilic esophagitis | January |
| immune globulin infusion 10% (Human) with recombinant Human hyaluronidase | HyQvia® | Takeda | Chronic inflammatory demyelinating polyneuropathy | January |
| immune globulin infusion (Human) | Gammagard Liquid® | Takeda | Chronic inflammatory demyelinating polyneuropathy | January |
| omalizumab | Xolair® | Genentech and Novartis | Reduction of allergic reactions, that may occur with an accidental exposure to one or more foods | February |
| bictegravir/emtricitabine/tenofovir alafenamide | Biktarvy® | Gilead | Expanded indication for HIV-1 infection with M184V/I resistance | February |
| maralixibat | Livmarli® | Mirum | Expanded pediatric indication for cholestatic pruritis with progressive familial intrahepatic cholestasis (PFIC) | March |
| spesolimab-sbzo | Spevigo® | BI | Generalized pustular psoriasis | March |
| Factor IX, recombinant | Ixinity® | Medexus | Expanded pediatric indication (<12 years of age) for hemophilia B | March |
Oncology drug approvals – 2024
| Generic Name | Brand Name | Manufacturer | Indication(s) | Route of Administration | Month Approved |
| tislelizumab-jsgr | Tevimbra® | BeiGene | Esophageal squamous cell carcinoma | IV | March |
New indications for approved oncology medications – 2024
| Generic Name | Brand Name | Manufacturer | New Indication | Month Approved |
| ponatinib | Iclusig® | Takeda | Front-line treatment of adults newly diagnosed with Philadelphia chromosome-positive (Ph+) ALL | March |
| nivolumab | Opdivo® | BMS | In combination with cisplatin and gemcitabine chemotherapy for first-line treatment of adults with unresectable or metastatic urothelial carcinoma (UC) | March |
| inotuzumab ozogamicin | Besponsa® | Pfizer | Relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in pediatric patients 1 year and older | March |
| zanubrutinib | Brukinsa® | BeiGene | In combination with obinutuzumab for treatment of adults with relapsed or refractory follicular lymphoma (r/r FL) after at least two prior lines of systemic therapy | March |
| irinotecan liposome | Onivyde® | Ipsen | First-line treatment of metastatic pancreatic ductal adenocarcinoma | February |
| osimertinib | Tagrisso® | AstraZeneca | In combination with pemetrexed and platinum chemotherapy for first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations | February |
| alpelisib | Piqray® | Novartis | Pre- and perimenopausal women for use in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, 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 at least one line of systemic therapy | January |
Biosimilars and gene/cell therapy drug approvals
Biosimilar approvals
| Generic Name | Brand Name | Reference Product | Manufacturer | Indication(s) | Route of Administration | Month Approved |
| denosumab-bbdz
|
Jubbonti® | Prolia® (Interchangeable) |
Sandoz | Bone health | SC | March |
| denosumab-bbdz | Wyost® | Xgeva® (Interchangeable) |
Sandoz | Bone health | SC | March |
| tocilizumab-aazg | Tyenne® | Actemra® | Fresenius Kabi | Autoimmune | IV/SC | March |
| adalimumab-ryvk
|
Simlandi® | Humira® (Interchangeable of high concentration (100 mg/mL citrate-free) |
Alvotech and Teva | Autoimmune | SC | February |
New indications for approved biosimilars – 2024
| Generic Name | Brand Name | Manufacturer | New Indication | Month Approved |
| pegfilgrastim-bmez | Ziextenzo® | Sandoz | Hematopoietic subsyndrome of acute radiation syndrome | February |
Gene/cell therapy approvals – 2024
| Generic Name | Brand Name | Manufacturer | Indication(s) | Route of Administration | Month Approved |
| atidarsagene autotemcel | Lenmeldy™ | Orchard | Early-onset metachromatic leukodystrophy | IV | March |
| lifileucel | Amtagvi™ | Iovance | Unresectable or metastatic melanoma | IV | February |
New indications for approved gene/cell therapy products – 2024
| Generic Name | Brand Name | Manufacturer | Indication(s) | Month Approved |
| lisocabtagene maraleucel | Breyanzi® | BMS | Relapsed or refractory chronic lymphocytic or small lymphocytic lymphoma who received at least 2 lines of therapy | March |
| exagamglogene autotemcel | Casgevy® | Vertex/CRISPR | Transfusion-dependent beta-thalassemia | January |
Related news
Perspectives
May 15, 2024
High-Cost Therapy Profile
Detailed information about Fidanacogene elaparvovec-dzkt Intravenous (IV)
Perspectives
May 15, 2024
June 2024 decisions expected from the FDA
Your monthly synopsis of new drugs expected to hit the market
Perspectives
May 15, 2024
Oncology Insights: First-in-class bladder cancer therapy and the Bacillus Calmette-Guérin (BCG) shortage
Approximately 83,000 new bladder cancer cases are diagnosed in the U.S. in each year. Here’s a look at the recent advancements and treatment options for bladder cancer, as well as an update on the BCG shortage.