FDA approves Praluent

FDA approved a BLA on Friday for PCSK9 inhibitor Praluent alirocumab from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:SAN; NYSE:SNY). The human mAb against PCSK9 is the first approved in the U.S. to treat high cholesterol.

The therapy is indicated as an adjunct to diet and maximally tolerated statin therapy in patients with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease who require additional cholesterol lowering therapy. The sponsors had sought a broader indication that included patients with mixed dyslipidemia. ...