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.