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."