FDA is reviewing three supplemental biologics license applications (sBLAs) that could help Sanofi and Regeneron Pharmaceuticals Inc.'s Praluent (alirocumab) return to labeling parity with Amgen Inc.’s competing PCSK9 inhibitor Repatha (evolocumab).
Praluent beat Repatha to approval by six weeks in 2015 to an indication in high-risk patients – those with the genetic disorder heterozygous familial hypercholesterolemia (HeFH) or with clinical atherosclerotic cardiovascular disease (ASCVD) -- who require additional LDL-cholesterol lowering despite maximally tolerated statin therapy