Table 8.
Selected Drugs and Biologicals That Have Already or May Receive FDA Labeling Approval in 2021a
| Drug or Biological | Manufacturer(s) | Indication(s) | Route | Type of Application | PDUFA Date (Month or Quarter)b |
|---|---|---|---|---|---|
| Umbralisib | TG Therapeutics | Relapsed or refractory marginal zone lymphoma and follicular lymphoma | Oral | NDA | Approved (Feb) |
| Trilaciclib | G1 Therapeutics | Decrease incidence of chemotherapy-induced myelosuppression | IV | NDA | Approved (Feb) |
| Casimersen | Sarepta Therapeutics | Duchenne muscular dystrophy | IV | NDA | Approved (Feb) |
| Melphalan Flufenamide | Oncopeptides | Multiple myeloma | IV | NDA | Approved (Feb) |
| Fosdenopterin | BridgeBio | Molybdenum cofactor deficiency type A | IV | NDA | Approved (Feb) |
| Arimoclomol | Orphazyme | Niemann-Pick disease type C | Oral | NDA | Q1 |
| Aducanumab | Biogen, Eisai | Alzheimer’s disease | IV | BLA | Q1 |
| Roxadustat | FibroGen, AstraZeneca | Anemia due to kidney disease | Oral | NDA | Q1 |
| Idecabtagene Vicleucel | bluebird bio, Bristol-Myers Squibb | Multiple myeloma | IV | BLA | Q1 |
| Abrocitinib | Pfizer | Atopic dermatitis | Oral | NDA | Q2 |
| Pegcetacoplan | Apellis | Paroxysmal nocturnal hemoglobinuria | IVI | NDA | Q2 |
| Avalglucosidase Alfa | Sanofi | Pompe disease | IV | BLA | Q2 |
| Loncastuximab Tesirine | ADC Therapeutics | Relapsed or refractory diffuse large B-cell lymphoma | IV | BLA | Q2 |
| Belumosudil | Kadmon | Chronic graft-vs-host disease | Oral | NDA | Q2 |
| Ibrexafungerp | Scynexis | Vulvovaginal candidiasis | Oral | NDA | Q2 |
| Tanezumab | Pfizer, Eli Lilly | Chronic pain due to moderate to severe osteoarthritis | SC | BLA | Q2 |
| Tralokinumab | AstraZeneca, LEO Pharma | Atopic dermatitis | SC | BLA | Q2 |
| Teplizumab | Provention Bio | Delay or prevention of type 1 diabetes in at-risk individuals | IV | BLA | Q3 |
| Avacopan | ChemoCentryx | Antineutrophil cytoplasmic antibody–associated vasculitis | Oral | NDA | Q3 |
| Bimekizumab | UCB | Plaque psoriasis | SC | BLA | Q3 |
| Reltecimod | Atox Bio | Necrotizing soft tissue infections | IV | NDA | Q3 |
| Amivantamab | Janssen | Metastatic non–small cell lung cancer | IV | BLA | Q4 |
| Odevixibat | Albireo | Pediatric cholestatic liver diseases | Oral | NDA | Q4 |
| Sotorasib | Amgen | Metastatic non–small cell lung cancer | Oral | NDA | Q4 |
| Narsoplimab | Omeros | Hematopoietic stem cell transplant–associated thrombotic microangiopathy | SC | BLA | Q4 |
Abbreviations: FDA, Food and Drug Administration; BLA, biologics license application; IV, intravenous; IVI, intravitreal injection; NDA, new drug application; PDUFA, Prescription Drug User Fee Act; Q, quarter; SC, subcutaneous.
aInformation for this table extracted from the IPD Analytics Brand and Biosimilar Pipeline database (see extended methods description in supplemental online material).
bExtrapolated on basis of NDA submission date and review status (ie, 10 months for standard review and 6 months for priority review). Some agents listed may have been approved by the time of publication.