Repatha evolocumab regulatory update

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 15-0 to support approval of Repatha evolocumab from Amgen to treat homozygous familial hypercholesterolemia (HoFH). The panel also voted 11-4 to support approval of the human mAb against PCSK9 to treat other forms of hyperlipidemia. The BLA has an Aug. 27 PDUFA date.

Among the 11 panelists who voted “yes” on the latter question, 8 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, and none supported approval for mixed dyslipidemia. ...