A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2023

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

Naunyn-Schmiedeberg's Archives of Pharmacology, cilt.397, sa.5, ss.2949-2970, 2024 (SCI-Expanded) identifier identifier

  • Yayın Türü: Makale / Derleme
  • Cilt numarası: 397 Sayı: 5
  • Basım Tarihi: 2024
  • Doi Numarası: 10.1007/s00210-024-03063-1
  • Dergi Adı: Naunyn-Schmiedeberg's Archives of Pharmacology
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, BIOSIS, Biotechnology Research Abstracts, CAB Abstracts, Chemical Abstracts Core, Chimica, Veterinary Science Database
  • Sayfa Sayıları: ss.2949-2970
  • Anahtar Kelimeler: FDA, First-in-class, New drugs, Next-in-class
  • Ankara Üniversitesi Adresli: Evet

Özet

With 54 new drugs and seven cellular and gene therapy products, the approvals by the US Food and Drug Administration (FDA) recovered 2023 from the 2022 dent back to the levels of 2020–2021. As in previous years of this annual review, we assign these new drugs to one of three levels of innovation: first drug against a condition (“first-in-indication”), first drug using a novel molecular mechanism (“first-in-class”), and “next-in-class,” i.e., a drug using an already exploited molecular mechanism. We identify four (7%) “first-in-indication,” 22 (36%) “first-in-class,” and 35 (57%) “next-in-class” drugs. By treatment area, rare diseases (54%) and cancer drugs (23%) were once again the most prevalent (and partly overlapping) therapeutic areas. Other continuing trends were the use of accelerated regulatory approval pathways and the reliance on biopharmaceuticals (biologics). 2023 marks the approval of a first therapy based on CRISPR/Cas9 gene editing.