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Esperion Announces FDA Approval of the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine
- NEXLIZET Lowered LDL-C by 38 Percent Compared to Placebo when Added on to Maximally Tolerated Statins -- First Non-Statin, LDL-Cholesterol Lowering
About this update from Esperion Therapeutics, Inc.
[{"type":"text","content":"- NEXLIZET Lowered LDL-C by 38 Percent Compared to Placebo when Added on to Maximally Tolerated Statins -- First Non-Statin, LDL-Cholesterol Lowering Combination Medicine Ever Approved -- Esperion’s Second Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Approved in the U.S. Following NEXLETOL™ (bempedoic acid) Tablet Approval on February 21, 2020 -- Further Underscores Esperion’s Commitment to Patient Affordability -- Conference Call and Webcast on Thursday, February 27 at 8:00 a.m. Eastern Time -\n ANN ARBOR, Mich., Feb. 26, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced that the U.S. Food and Drug Administration (FDA) approved NEXLIZET™ (bempedoic acid and ezetimibe) tablet, an oral, once-daily, non-statin LDL-Cholesterol (LDL-C), lowering medicine. NEXLIZET is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C. The effect of NEXLIZET on cardiovascular morbidity and mortality has not been determined. NEXLIZET is the first non-statin, LDL-C lowering combination medicine ever approved. This approval follows the approval of NEXLETOL™ (bempedoic acid) tablet last week. NEXLIZET 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 approval of NEXLIZET underscores Esperion’s commitment to providing patients and their healthcare providers with innovative non-statin medicines that fit into their everyday routines to lower elevated levels of bad cholesterol in adult patients with ASCVD or HeFH on maximally tolerated statins. This is the first non-statin combination medicine ever approved for lowering LDL-C,” said Tim M. Mayleben, president and chief executive officer of Esperion. “We are truly grateful to all of the patients and healthcare providers who put their confidence in Esperion’s team of lipid experts.” LDL-C is a waxy, fat-like substance that’s found in the body. Elevated LDL-C contributes to a buildup of this fat in the arteries and can lead to cardiovascular events including heart attack and stroke. Despite standard of care treatments, it is estimated ...