The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has recommended approval of the investigational PCSK9 inhibitor alirocumab (Praluent, Regeneron and Sanofi) injection for treatment of hypercholesterolemia, according to a press release.
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 to recommend approval 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.
Common adverse events that were more frequently reported in the alirocumab groups vs. control groups included injection site reaction and pruritis.
Although the FDA is not required to follow the advisory panel’s recommendation, it usually does. The Biologics License Application for alirocumab was accepted for priority review by the FDA with a target action date of July 24, 2015.
If approved, alirocumab is expected to be the first fully human monoclonal antibody targeting PCSK9 in the United States.
“We are pleased with the committee’s recommendation to approve Praluent. Our clinical trial program focused on patients with high unmet need in which Praluent delivered significant reductions in LDL on top of statins and other lipid-lowering therapies,” Elias Zerhouni, MD, president of Global R&D at Sanofi, said in the release.