FDA Advisory Committee to review Repatha (evolocumab)for treatment of high cholesterol on 10 June 2015-Amgen

Amgen has announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA will review data supporting the Company's Biologics License Application (BLA) for Repatha (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 EMDAC will review results from clinical trials in support of the BLA for Repatha, which is based on data from approximately 6,800 patients, including more than 4,500 patients with high cholesterol in 10 Phase III trials. The Phase III studies evaluated the safety and efficacy of Repatha in patients with elevated cholesterol, including patients on statins with or without other lipid-lowering therapies; patients who cannot tolerate statins; patients with heterozygous familial hypercholesterolemia (HeFH) and patients with homozygous familial hypercholesterolemia (HoFH), a rare and serious genetic disorder.The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Aug. 27, 2015, for the Repatha BLA.