A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2021

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KAYKI MUTLU G., Aksoyalp Z. S., Wojnowski L., Michel M. C.

NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY, cilt.395, sa.8, ss.867-885, 2022 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Derleme
  • Cilt numarası: 395 Sayı: 8
  • Basım Tarihi: 2022
  • Doi Numarası: 10.1007/s00210-022-02250-2
  • Dergi Adı: NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, BIOSIS, Biotechnology Research Abstracts, CAB Abstracts, Chemical Abstracts Core, Chimica, EMBASE, MEDLINE, Veterinary Science Database
  • Sayfa Sayıları: ss.867-885
  • Anahtar Kelimeler: FDA, New drugs, First-in-indication, First-in-class, Next-in-class, CABOTEGRAVIR PLUS RILPIVIRINE, PREVIOUSLY TREATED RECURRENT, VILOXAZINE EXTENDED-RELEASE, PLACEBO-CONTROLLED TRIAL, RENAL-CELL CARCINOMA, PARALLEL-GROUP TRIAL, DOUBLE-BLIND, OPEN-LABEL, AMIVANTAMAB JNJ-61186372, AVALGLUCOSIDASE ALPHA
  • Ankara Üniversitesi Adresli: Evet

Özet

The second year of the COVID-19 pandemic had no adverse effect on the number of new drug approvals by the US Food and Drug Administration (FDA). Quite the contrary, with a total of 50 new drugs, 2021 belongs to the most successful FDA years. We assign these new drugs to one of three levels of innovation: (1) first drug against a condition ("first-in-indication"), (2) first drug using a novel molecular mechanism ("first-in-class"), and (3) "next-in-class", i.e., a drug using an already exploited molecular mechanism. We identify 21 first-in-class, 28 next-in-class, and only one first-in-indication drugs. By treatment area, the largest group is once again cancer drugs, many of which target specific genetic alterations. Every second drug approved in 2021 targets an orphan disease, half of them being cancers. Small molecules continue to dominate new drug approvals, followed by antibodies and non-antibody biopharmaceuticals. In 2021, the FDA continued to approve drugs without strong evidence of clinical effects, best exemplified by the aducanumab controversy.