FDA Panel Favors Approval of Alirocumab for Hypercholesterolemia

The FDA’s Endocrinologic and Metabolic Advisory Committee has recommended approval of the first PCSK9 inhibitor alirocumab (Praluent, Regeneron and Sanofi) injection for treatment of hypercholesterolemia. In a 13-3 vote, the panel decided that the LDL-lowering benefit of alirocumab outweighed the risks in one or more patient populations. The committee based its decision on a review of safety and efficacy data from 10 pivotal phase 3 double-blind trials evaluating more than 5,000 patients for 6 months to 2 years. Clinical data from the ODYSSEY phase 3 program demonstrated consistent, positive results for alirocumab’s ability to lower LDL cholesterol, according to the release. More news soon.