PCSK9 Inhibitor Labeling Parity Is Within Reach As Praluent And Repatha Strive To Make Commercial Case

Sanofi and Regeneron’s Praluent could draw even with Amgen’s US Repatha in approved FDA indications in 2019. While the injectable PCSK9 inhibitors battle for payers and prescribers, Esperion is readying its oral bempedoic acid to join the lipid-lowering fray – and strategizing towards what could be the first statin intolerance indication.

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

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