FDA Panel Advises Praluent PCKS9 Inhibitor Approval

An FDA panel has recommended approval for alirocumab (Praluent) in patients with high cholesterol.

At separate advisory meetings, FDA officials voted in favor of approval for 2 proposed proprotein convertase subtilisin kexin 9 (PCKS9) inhibitors for lowering low-density lipoprotein cholesterol levels: Sanofi and Regeneron’s alirocumab and Amgen’s evolocumab (Repatha).

“The discovery of PCSK9 as a powerful regulator of cholesterol levels and cardiovascular disease was one of the most important human genetic advances of the last decade,” stated George Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories. “ (This) outcome brings us one step closer to translating this genetics-based discovery into a treatment that may help the many patients in need of additional cholesterol lowering.”

In a 13-3 vote, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee demonstrated a favorable opinion of Praluent’s benefit-risk profile to support its approval.

This recommendation followed the committee’s review of efficacy and safety data from Praluent’s phase 3 ODYSSEY trial program. Common adverse events in Praluent-treated participants included injection site reaction and pruritus.

The FDA is expected to act on Praluent’s biologics license application (BLA) on July 24, 2015. If approved on that date, it would become the first fully human monoclonal antibody targeting PCSK9 in the United States, as the FDA isn’t expected to act on Repatha’s BLA until August 27, 2015.