The Committee's recommendation was based on Praluent's benefit-risk profile, following review of efficacy and safety data from more than 5,000 patients across 10 pivotal Phase 3 double-blind trials ranging from six months to two years. Clinical data from the ODYSSEY Phase 3 program show consistent, positive results in reducing LDL-C. Common adverse events that were more frequently reported in patients treated with Praluent than the control groups included injection site reaction and pruritus (itching).
The Advisory Committee's recommendation will be considered by the FDA in its review of the Biologics License Application (BLA) for Praluent. The FDA is not bound by the Committee's recommendation, but takes its advice into consideration when reviewing investigational medicines. The BLA for Praluent was accepted for priority review by the FDA with a target action date of July 24, 2015.
If approved by the FDA, Praluent is expected to be the first fully human monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in the U.S. The Marketing Authorization Application for Praluent in the European Union is currently under review by the European Medicines Agency (EMA). The safety and efficacy of Praluent have not been fully evaluated by any regulatory authority.
