Amgen Submits MAA for Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab to EMA

Amgen has announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) via the centralised 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.

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The MAA for evolocumab contains data from approximately 6800 patients, including more than 4500 patients with high cholesterol in 10 Phase III trials. The Phase III 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.

"Following last week's filing submission to FDA, the submission of the MAA to EMA represents another significant milestone in our global lipid-lowering development programme," said Sean E. Harper, MD, Executive Vice President of R&D 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."