FDA Committee to Review Amgen’s New Anti-Cholesterol Drug Evolocumab
Amgen reports that the Endocrinologic and Metabolic Drugs Advisory Committee Committee (EMDAC) of the US Food and Drug Administration (FDA) will review data supporting the company’s biologics license application (BLA) for RepathaT (evolocumab) for the treatment of high cholesterol at a meeting on June 10, 2015. Repatha 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 FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Aug. 27, 2015, for the Repatha BLA.
In seeking approval of evolocumab, Amgen is competing against two other late-stage PCSK9 inhibitors respectively from Sanofi and Pfizer. Sanofi has submitted regulatory filings in the US and EU for Praluent (alirocumab), an investigational monoclonal antibody targeting PCSK9, for which Sanofi is partnered with Regeneron Pharmaceuticals. In January 2015, the FDA accepted for priority review the BLA for the drug with a target action date of July 24, 2015. Also, the European Medicines Agency accepted for review the marketing authorization application for Praluent in the European Union.
Pfizer currently is studying bococizumab, an investigational PCSK9 inhibitor, in a Phase III clinical trial program for its potential to lower LDL-C and improve cardiovascular outcomes.