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TL;DR
This narrative review of FDA-approved new molecular entities in 2022 found 37 approvals, below the 10-year average of 43, but with a higher share of first-in-class drugs (54%) and the highest proportion of biologics on record.
Naunyn-Schmiedeberg's Archives of Pharmacology · 4 authors, 3 centres
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This narrative review of FDA-approved new molecular entities in 2022 found 37 approvals, below the 10-year average of 43, but with a higher share of first-in-class drugs (54%) and the highest proportion of biologics on record.
Approvals were below the rolling 10-year average of 43 and lower than the 53 and 50 approvals in 2020 and 2021, which the authors suggest may partly reflect COVID-19 effects on clinical trial recruitment and manufacturing inspections. First-in-class drugs accounted for 54% of approvals, up from 42% in 2021. Orphan Drug Act and commercial incentives. Biopharmaceuticals represented nearly half of all approvals, the highest yearly proportion to date. Accelerated regulatory pathways were frequently used, with 57% receiving priority review. Limitations include the focus exclusively on FDA approvals, exclusion of vaccines and biosimilars, and the absence of comparative clinical benefit or pricing analyses.