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 |
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