Amgen Announces FDA Advisory Committee Meeting to Review Repatha (Evolocumab) as a Treatment for High Cholesterol

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 10 June 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.

"There is a critical need for additional treatment options for high-risk patients who are unable to control their high cholesterol with currently available therapies," said Sean E. Harper, executive vice president of R&D at Amgen. "We look forward to discussing the efficacy and safety data from our clinical program with the members of the Committee."

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 3 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 27 August 2015, for the Repatha BLA.