On Wednesday, June 10, 2015, the Endocrinologic and Metabolic Advisory Committee (EMDAC) supported, by a vote of 11-Yes to 4-No, with no abstentions the safety and efficacy of REPATHA (Evolocumab) for injection, submitted by Amgen Inc. (Amgen) for the treatment of high cholesterol (BLA Number 125522). A description of the patient populations that apply to this vote is included in the section of this report "Key Outcomes of Advisory Meeting.” The EMDAC also supported REPATHA, by a vote of 15-Yes and 0-No, with no abstentions for its proposed use to treat patients with homozygous hypercholesterolemia.
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Earlier Event: June 9Endocrinologic and Metabolic Drugs Advisory Committee
Later Event: June 11Pulmonary-Allergy Drugs Advisory Committee Meeting