Esperion reports FDA confirms path to approval for LDL-C lowering indication
Esperion Therapeutics announced the U.S. Food and Drug Administration recently confirmed that Esperion's LDL-C lowering program is adequate to support approval of an LDL-C lowering indication for bempedoic acid. Esperion plans to submit a new drug application, or NDA, by 1H 2019 for an LDL-C lowering indication based on the successful completion of the global pivotal Phase 3 program. The proposed product label would include specific language for use of bempedoic acid as an adjunct to maximally tolerated statin therapy in patients with hypercholesterolemia, specifically those at high cardiovascular disease risk with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia who require additional LDL-C lowering. Interactions with FDA also addressed the ongoing cardiovascular outcomes trial, Cholesterol Lowering via BEmpedoic Acid, an ACL-inhibiting Regimen Outcomes for bempedoic acid in patients with or at high risk for CVD who are only able to tolerate less than the lowest approved daily starting dose of a statin and are considered statin intolerant. For purposes of the CVOT, agreement has been reached with FDA that the following definition of statin intolerance is acceptable for the CVOT: "the inability to tolerate two or more statins, one at the lowest approved daily starting dose, due to an adverse effect," as defined in CLEAR Outcomes. The lowest approved daily starting statin doses include an average daily dose of less than5 mg rosuvastatin, less than10 mg of atorvastatin, less than10 mg simvastatin, less than20 mg lovastatin, less than40 mg pravastatin, less than40 mg fluvastatin and less than2 mg of pitavastatin. In CLEAR Outcomes, patients and investigators will provide written confirmation that the patient is statin intolerant and that the patient is aware of the benefits of statins in reducing the risk of cardiovascular events and death. The Company expects to submit an NDA for a cardiovascular disease risk reduction indication to the FDA and a Marketing Authorization Application to the European Medicines Agency by 2022, upon successful completion of CLEAR Outcomes.