Esperion presents pooled analyses from four Phase 3 bempedoic acid studies
Esperion announced that pooled analyses from four Phase 3 clinical studies of bempedoic acid were presented at the American Heart Association, or AHA, Scientific Sessions in Philadelphia. Bempedoic acid is being developed as a convenient, once-daily, oral therapy for the treatment of patients with elevated low-density lipoprotein cholesterol added onto maximally tolerated statin therapy. Bempedoic acid and the bempedoic acid 180 mg + ezetimibe 10 mg fixed dose combination tablets' new drug applications are currently under regulatory review by the FDA and the marketing authorisation applications are currently under centralized review by the European Medicines Agency, or EMA. "We are very pleased with the pooled analyses from the Phase 3 LDL-C lowering clinical development program showing bempedoic acid not only lowered LDL-C by 25% but also reduced HbA1c by 0.19% in 1,134 patients with diabetes," said Tim Mayleben, CEO of Esperion. "These pooled analyses further support our confidence that bempedoic acid could be a convenient and important, oral, once-daily drug for the millions of patients on maximally tolerated statin therapy who need additional LDL-C lowering."