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37 new drugs achieved FDA approval in 2022

Fewer new molecular entities cleared the agency’s hurdles than in recent years

by Bethany Halford
January 21, 2023 | A version of this story appeared in Volume 101, Issue 3


The past year was a relatively slow one for approvals of new drugs by the US Food and Drug Administration. The agency gave its nod to 37 new molecular entities in 2022. By comparison, there were 50 new approvals in 2021, 53 in 2020, 48 in 2019, and a record high of 59 in 2018. Seventeen of 2022’s new drugs were small molecules, accounting for 46%. That’s also a decline from 2021 and 2020, when small molecules made up 62 and 66% of the new drugs, respectively.

But the drop in approvals doesn’t mean there was a decline in drugmakers’ innovation. Eli Lilly and Company’s Mounjaro (tirzepatide), a weekly injectable for type 2 diabetes, mimics two gut hormones involved in blood sugar regulation—glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). The FDA first approved exenatide, a synthetic version of GLP-1, in 2005, but Mounjaro is the first to feature a GIP mimic.

Bristol Myers Squibb’s Sotyktu (deucravacitinib), one of several treatments for psoriasis approved in 2022, is the first drug to include deuterium from its inception. Molecule aficionados will also appreciate the complex, fluorine-festooned structure of Gilead Sciences’ HIV treatment Sunlenca (lenacapavir).

Because C&EN tracks approvals from the FDA’s Center for Drug Evaluation and Research, our tabulation does not include blood products, gene therapies, vaccines, and other therapies that are approved by the FDA’s Center for Biologics Evaluation and Research. For example, this center approved Moderna’s Spikevax, a messenger RNA vaccine designed to prevent COVID-19, in January 2022.

Slower pace
In 2022, the US Food and Drug Administration approved 37 novel drugs, down from 50 in 2021 and 53 in 2020.
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C&EN lists 2022's new drug approvals.


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