2022 below annual average of novel drug approvals: 5 report notes

The FDA approved 37 novel drugs in 2022 — the third lowest number since 2013 — according to a Jan. 10 agency report.  

These novel drug approvals — meaning new products never before approved or marketed in the U.S. — and drugs approved in new settings included treatments for diseases and conditions such as COVID-19; HIV; smallpox; influenza; neurological conditions; heart, blood, kidney and endocrine diseases; and different cancers. 

Here are four other things to know from the FDA's Center for Drug Evaluation and Research report:

1. 2022 saw the 40th FDA-approved biosimilar. 

2. Fifty-four percent of the novel drug approvals were for rare diseases, including a rare cancer that begins in the eye. 

3. Twenty-five of the 37 novel approvals, or 68 percent, were first approved in the U.S.

4. Fifty-four percent were first-in-class drugs, meaning they had "mechanisms of action different from those of existing therapies."

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