Hypercholesterolemia Treatment Granted FDA Priority Review

January 27, 2015
Ryan Marotta, Assistant Editor

Sanofi and Regeneron Pharmaceuticals recently announced that the FDA has accepted for priority review a Biologics License Application for their investigational drug, alirocumab, which is indicated for patients with hypercholesterolemia.

Sanofi and Regeneron Pharmaceuticals recently announced that the FDA has accepted for priority review a Biologics License Application (BLA) for their investigational drug, alirocumab (Praluent), which is indicated for patients with hypercholesterolemia.

The FDA’s goal for completing its priority review of Praluent is 6 months, with a target action date set for July 24, 2015.

The BLA for Praluent contains data from more than 5000 patients, including the participants of 10 phase 3 trials. In total, the Odyssey clinical trial program evaluating Praluent will enroll more than 23,500 patients at more than 2000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years.

Sanofi and Regeneron reported positive results from 2 of those trials earlier this month.

To date, no regulatory authority has fully evaluated the safety and efficacy of Praluent, a monoclonal antibody that targets proprotein convertase subtilisin/kexin type 9.