Amgen announced that the FDA has accepted for review the Biologics License Application (BLA) for evolocumab for the treatment of high cholesterol. Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).
The BLA submission is based on data from approximately 6,800 patients, including more than 4,500 patients with high cholesterol in ten 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).
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