Praluent alirocumab regulatory update

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 13-3 to support approval of Praluent alirocumab from Sanofi and Regeneron to treat hyperlipidemia. The BLA for the human mAb targeting PCSK9 is under Priority Review with a July 24 PDUFA date.

Six panel members who supported approval felt that approval of Praluent should be restricted to patients with heterozygous familial hypercholesterolemia (HeFH), while the other 7 thought approval should be extended to high-risk cardiovascular patients whose LDL is not well controlled by maximally tolerated statins. ...