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News From the Food and Drug Administration
July 21, 2015

Thumbs Up for PCSK9 Inhibitors

JAMA. 2015;314(3):217. doi:10.1001/jama.2015.7582

People at risk of cardiovascular disease from elevated cholesterol levels who don’t respond to or cannot tolerate statins may soon have new treatment options.

An advisory committee recommended in early June that the FDA approve 2 new drugs that inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that impairs the liver’s ability to remove harmful low-density lipoprotein cholesterol (LDL-C) from the blood. The Endocrinologic and Metabolic Drugs Advisory Committee gave the first thumbs up to alirocumab, a product of Sanofi and Regeneron Pharmaceuticals (http://bit.ly/1fBPNpC). The drug is intended for patients with familial hypercholesterolemia, those with mixed dyslipidemia, or those who can’t tolerate statins.

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