2021 FDA approvals

The FDA approved 50 novel drugs in 2021, including the first KRAS inhibitor for cancer and the first anti-amyloid antibody for Alzheimer’s disease.

Article by Asher Mullard – Nature Reviews Drug Discovery – 04 January 2022

The FDA’s approval count last year was in line with recent trends, despite the continued impact of COVID-19. The agency’s Center for Drug Evaluation and Research (CDER) approved 50 novel therapeutics in 2021, down from 53 in 2020 .The 5-year average sits at 51 drugs per year. A decade ago, it was 24 drugs per year.

TABLE 1 | CDER APPROVALS IN 2021

^aBiologic approval. ^bWithdrawn later in the year. A, accelerated; ADC, antibody–drug conjugate; ADHD, attention deficit hyperactivity disorder; ALL, acute lymphoblastic leukaemia; ASCVD, atherosclerotic cardiovascular disease; ASO, antisense oligonucleotide; B, breakthrough; CKD, chronic kidney disease; CMV, cytomegalovirus; CNP, C type natriuretic peptide; cPMP, cyclic pyranopterin monophosphate; DMD, Duchenne muscular dystrophy; FR, folate receptor; GHD, growth hormone deficiency; GVHD, graft-versus-host disease; HeFH, heterozygous familial hypercholesterolaemia; HoFH, homozygous familial hypercholesterolaemia; IBAT, ileal bile acid transporter; INSTI, integrase strand transfer inhibitor; LBL, lymphoblastic lymphoma; mAb, monoclonal antibody; MoDC, molybdenum cofactor deficiency; MR, mineralocorticoid receptor; MZL, marginal zone lymphoma; NSCLC, non-small-cell lung cancer; NNRTI, non-nucleoside reverse transcriptase inhibitor; O, orphan; P, priority; PEG, polyethylene glycol; Ph⁺ CML, Philadelphia chromosome-positive chronic myeloid leukaemia; PNH, paroxysmal nocturnal haemoglobinuria; S1P, sphingosine 1-phosphate; sGC, soluble guanylate cyclase; siRNA, small interfering RNA; SLE, systemic lupus erythematosus; SNRI, selective noradrenaline reuptake inhibitor; TSLP, thymic stromal lymphopoietin. Source: Drugs@FDA.

Further approvals from the FDA’s Center for Biologics Evaluation and Research (CBER) additions include a landmark mRNA vaccine and CAR-T cell products (Table 2). Emergency Use Authorizations (EUAs) made the news too, with antibodies and rapidly developed oral antivirals for COVID-19 (Table 3). CBER approvals and EUAs are not included in the annual new drug count, however.

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Article information: Asher Mullard. Nature Reviews Drug Discovery (Nat Rev Drug Discov), ISSN 1474-1784 (online). doi: https://doi.org/10.1038/d41573-022-00001-9