Background Analysis: US FDA Advisory Committee to Review Amgen’s REPATHA for High Cholesterol – JUN 10, 2015 (EMDAC)
The US FDA has scheduled an Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting for Wednesday, June 10, 2015. The Committee will discuss the safety and efficacy of REPATHA (Evolocumab) for injection, submitted by Amgen Inc. for the treatment of high cholesterol (BLA Number 125522). The proposed indication is for use as adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (ApoB), non- high-density lipoprotein cholesterol (non-HDL-C), TC/HDL-C, ApoB/ApoA1, very low-density lipoprotein cholesterol, triglyceride , and lipoprotein A , and to increase HDL-C and ApoA1, in adults with hyperlipidemia or mixed dyslipidemia, either in combination with a statin or statin with other lipid-lowering therapies (e.g., ezetimibe), or alone, or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or alone or in combination with other lipid-lowering therapies in patients for whom a statin is not considered clinically appropriate and to reduce LDL-C, TC, ApoB, and no -HDL-C, in combination with other lipid-lowering therapies (e.g. statins, LDL apheresis) in patients at least 12 years of age with homozygous familial hypercholesterolemia.