Panel recommends FDA approve PCSK9 inhibitor alirocumab

The FDA’s advisory panel voted 13-3 in favor of alirocumab as an anticholesterol treatment, paving the way for what might become the first fully human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) in the U.S.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted June 9 on the safety and effectiveness of alirocumab (Praluent, Regeneron Pharmaceuticals and Sanofi Aventis) as a treatment for patients with hypercholesterolemia. The panel reviewed data from 10 pivotal Phase 3 double-blind trials on the ability of alirocumab to reduce low-density lipoprotein cholesterol (LDL-C) in patients with nonfamilial and heterozygous familial hypercholesterolemia.

On June 10, the same panel will discuss the risks and benefits of evolocumab (Repatha, Amgen), another PCSK9 inhibitor. The FDA has expressed concerns about which patient population is best treated with this therapy, which is an injectable.

The FDA granted alirocumab priority review early this year and is expected to make its decision no later than July 24. The agency often, but not always, follows the recommendations of its advisory panels.