EMA Accepts Sanofi’s MAA for Cholesterol Drug
Sanofi reports that the European Medicines Agency (EMA) has accepted for review the marketing authorization application (MAA) for Praluent (alirocumab). Praluent is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) that is intended for the treatment of patients with hypercholesterolemia.
A biologics license application (BLA) for Praluent was submitted to the US Food and Drug Administration (FDA) in the fourth quarter of 2014. In July 2014, Sanofi and its partner, Regeneron Pharmaceuticals, announced that the companies intend to use a FDA rare pediatric disease priority review voucher in connection with their BLA for alirocumab. The priority review voucher, which the companies acquired from BioMarin Pharmaceutical, entitles the holder to designate a BLA for priority review, which provides for an expedited six-month review from the filing date instead of the standard 10-month review.
Sanofi is one of several companies with late-stage PCSK9 inhibitors under development or under regulatory review. In November 2014, the FDA accepted Amgen’s BLA for evolocumab for the treatment of high cholesterol. Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood. The BLA was submitted on Aug. 27, 2014. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Aug. 27, 2015 for the evolocumab application. Pfizer’s bococizumab, also a PCKS9 inhibitor, is in Phase III development.