Praluent (alirocumab) is filed at the FDA for treatment of Hypercholesterolaemia- Sanofi + Regeneron

Sanofi and Regeneron Pharmaceuticals announced that the FDA has accepted for priority review the Biologics License Application (BLA) for Praluent (alirocumab). Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review is six months, for a target action date of 24 July 2015. Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) that is intended for the treatment of patients with hypercholesterolaemia.

Earlier this month, the companies announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.

Comment: Estimates have been made that some two thirds of treated high risk patients do not control their LDL-C. Evolocumab from Amgen is the closest competitor to Praluent and is already filed at EMA and the FDA with a US review date of 27 August 2015. Both drugs appear to be close in their effects of reducing the rates of LDL-C.