Amgen today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) via the centralized procedure for evolocumab seeking approval 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.1 ­

The MAA for evolocumab contains data from approximately 6,800 patients, including more than 4,500 patients with high cholesterol in 10 Phase 3 trials. The Phase 3 studies evaluated the safety and efficacy of evolocumab in patients with elevated cholesterol 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.2

"Following last week's filing submission to the U.S. FDA, the submission of the Marketing Authorization Application to the European Medicines Agency represents another significant milestone in our global lipid-lowering development program," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Across the European Union, uncontrolled high cholesterol is a burden on the health system, and we look forward to working with regulatory authorities in hopes of providing this new treatment option for patients at high cardiovascular risk with high cholesterol, who are unable to reach their LDL cholesterol goals with current therapies."

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