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Esperion Announces European Commission Approval of the NUSTENDI™ (bempedoic acid and ezetimibe) Tablet for the Treatment of Hypercholesterolemia and Mixed Dyslipidemia
– First Non-Statin, LDL-C Lowering Combination Medicine Ever Approved in Europe – – NUSTENDI Is Approved for Patients Who Require Additional LDL-Cholesterol
About this update from Esperion Therapeutics, Inc.
[{"type":"text","content":"– First Non-Statin, LDL-C Lowering Combination Medicine Ever Approved in Europe –\n – NUSTENDI Is Approved for Patients Who Require Additional LDL-Cholesterol Lowering on a Background Statin, Other Lipid-Lowering Therapies, or Considered Statin Intolerant – – Daiichi Sankyo Europe to Lead EU Commercialization, Cardiovascular Sales Organization Exceeds 1,000 Professionals – – Esperion to Receive $150 Million Milestone Payment Upon First Commercial Sale – ANN ARBOR, Mich., April 06, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) announced today the European Commission approved the NUSTENDI™ (bempedoic acid and ezetimibe) tablet, an oral, once-daily, non-statin LDL-cholesterol (LDL-C) lowering medicine for hypercholesterolemia and dyslipidemia in Europe. NUSTENDI contains bempedoic acid and ezetimibe and lowers elevated LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and absorption in the intestine. The European Commission approved NUSTENDI for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe,alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone, orin patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin. “For the first time, a non-statin once-a-day pill with significant efficacy will be available across Europe to fight bad cholesterol,” said Tim M. Mayleben, president and chief executive officer of Esperion. “This is a major advancement for the millions of patients needing an additional option to use with their statin and know it’s important for them to achieve recommended LDL-C goals or for those that may be statin intolerant.” The European Society of Cardiology and European Atherosclerosis Society recommend intensively lowering LDL-C to reduce cardiovascular risk. Even today, up to 80% of patients do not reach recommended LDL-C goals despite receiving treatments such as statins1, and are at increased risk of a heart attack or stroke. NUSTENDI provides patients and their physicians an importa...