FDA Accepts Amgen’s BLA for Cholesterol Drug EvolocumabBy
Amgen reports that the US Food and Drug Administration has accepted the company’s biologics license application (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.
Amgen is one of several companies with late-stage PCSK9 inhibitors under development. 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, a PCSK9 inhibitor. 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 and Regeneron expect to submit US and EU regulatory submissions for alirocumab by the end of the year. Pfizer’s bococizumab, also a PCKS9 inhibitor, is in Phase III development.