Bempedoic acid regulatory update

Esperion said FDA confirmed that its Phase III program for bempedoic acid is adequate to support approval in an LDL-C lowering indication. The company plans to submit regulatory applications to FDA and EMA by 1H19 for the ATP citrate lyase (ACLY) inhibitor. The news allayed investor fears that FDA would not accept LDL-C lowering as an approvable surrogate endpoint for cardiovascular (CV) benefit and that it would require data from a cardiovascular outcomes trial (CVOT) prior to the candidate’s approval. Esperion has said a requirement for CVOT data could push a U.S. launch back to 2023. Esperion plans to seek approval of bempedoic acid as an adjunct to maximally tolerated statin therapy to lower LDL-C in hypercholesterolemia patients at high risk for CV disease with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH). The company expects top-line data by mid-2018 from 3 Phase III LDL-C lowering studies and a long-term safety study (see BioCentury, July 11, 2016)...