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FDA panel backs Repatha

June 11, 2015 1:21 AM UTC

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 15-0 to support approval of Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN) to treat homozygous familial hypercholesterolemia (HoFH). The panel also voted 11-4 to support approval of the mAb against PCSK9 to treat other forms of hyperlipidemia.

Among the 11 panelists who voted "yes" on the latter question, eight supported approval to treat heterozygous familial hypercholesterolemia (HeFH) and high-risk cardiovascular patients whose LDL is not well controlled by maximally tolerated statins. Three supported approval for HeFH but not the broader high-risk group, while none supported approval for mixed dyslipidemia. ...