FDA approves Repatha

FDA approved a BLA for Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN), making it the second mAb against PCSK9 to gain U.S. approval. FDA approved Praluent alirocumab from Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) on July 24 (see BioCentury Extra, July 24).

The agency approved Repatha as an adjunct to diet and maximally-tolerated statin therapy in adults with heterozygous or homozygous familial hypercholesterolemia (HeFH or HoFH), or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL cholesterol. ...