FDA Accepts Amgen's Biologics License Application for Cholesterol Medication Evolocumab

WASHINGTON - Nov. 11, 2014 - PRLog -- The U.S. Food and Drug Administration (FDA) has accepted for review, Amgen’s Biologics License Application (BLA) for evolocumab to treat high cholesterol. The investigational monoclonal antibody functions by inhibiting a protein (PCSK9) known to reduce the liver’s capability to remove ‘bad’ or low-density lipoprotein cholesterol (LDL-C) from the blood.

"There is still a large unmet need among patients with high cardiovascular risk and elevated cholesterol who are unable to reach optimal LDL cholesterol levels with current therapies," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Evolocumab has the potential to provide significant additional benefit when added to existing LDL cholesterol-lowering medications for patients with high cholesterol."

Clinical studies assessed 6,800 patients which included 10 phase 3 studies evaluating 4, 500 individuals with high cholesterol. Evolocumab’s safety and efficacy was evaluated 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).

The Prescription Drug User Fee Act (PDUFA) target action date of Aug. 27, 2015 has been set by the FDA, for the evolocumab application.

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