A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2022.
Naunyn Schmiedebergs Arch Pharmacol
; 396(8): 1619-1632, 2023 Aug.
Artículo
en Inglés
| MEDLINE | ID: covidwho-2265850
ABSTRACT
While new drug approvals by the U.S. Food and Drug Administration (FDA) had remained stable or even increased in the first 2 years of the COVID-19 pandemic, the 37 newly approved drugs in 2022 are considerably less than the 53 and 50 new drugs approved in 2020 and 2021, respectively, and less than the rolling 10-year average of 43. 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 two "first-in-indication" (ganaxolon and teplizumab), 20 (54%) "first-in-class," and 17 (46%) "next-in-class" drugs. By treatment area, rare diseases and cancer drugs were once again the most prevalent (partly overlapping) therapeutic areas. Other continuing trends were the use of accelerated regulatory approval pathways and the reliance on biopharmaceuticals (biologics).
Palabras clave
Texto completo:
Disponible
Colección:
Bases de datos internacionales
Base de datos:
MEDLINE
Asunto principal:
Productos Biológicos
/
COVID-19
Límite:
Humanos
País/Región como asunto:
America del Norte
Idioma:
Inglés
Revista:
Naunyn Schmiedebergs Arch Pharmacol
Año:
2023
Tipo del documento:
Artículo
País de afiliación:
S00210-023-02465-x
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