====Esperion (ESPR) sees clear FDA path for its heart drug

Esperion announces the FDA confirmed that Esperion's LDL-C lowering program is adequate to support approval of an LDL-C lowering indication for bempedoic acid; expects to submit an NDA for cardiovascular disease risk reduction to the FDA and a MAA to EMA by 2022 upon completion of CLEAR Outcomes :

• Esperion plans to submit a new drug application 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 diseas 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
• Phase 3 program update:
• The Phase 3 clinical development program with a global pivotal 52-week long-term safety and tolerability study in patients with hypercholesterolemia at high CVD risk and whose LDL-C is not adequately controlled with current lipid-modifying therapies. Patient enrollment of more than 2,200 patients was completed in Jan 2017 and top-line results from this study are expected by Q2 2018. An open-label extension study of Study 1 was initiated in Feb 2017 to collect additional patient safety data.
• Top-line results from their long-term safety and tolerability study are expected by Q2 2018 with top-line results from the three LDL-C lowering efficacy studies expected by mid-2018. Submissions of an NDA to the FDA and a MAA to the EMA for an LDL-C lowering indication are expected by 1H 2019.