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Esperion Announces Submission of Supplemental New Drug Applications to U.S. FDA for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet
– Submitted four efficacy supplements seeking inclusion of CV risk reduction and expansion of LDL-C lowering – – Anticipated approvals in U.S. in the first
About this update from Esperion Therapeutics, Inc.
[{"type":"text","content":"– Submitted four efficacy supplements seeking inclusion of CV risk reduction and expansion of LDL-C lowering – – Anticipated approvals in U.S. in the first half of 2024 – ANN ARBOR, Mich., June 01, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has submitted Supplemental New Drug Applications (sNDA) to the U.S. Food and Drug Administration (FDA) for the Company’s oral non-statin products NEXLETOL and NEXLIZET. In its sNDAs, Esperion seeks to add the use of both NEXLETOL and NEXLIZET for cardiovascular risk reduction and also seeks to remove the statin limitation in the LDL-C indication. The sNDA submissions are based on the landmark Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial which showed NEXLETOL demonstrated significant cardiovascular risk reduction across a range of primary and second endpoints, including a 27% risk reduction of non-fatal myocardial infarction, a 23% risk reduction of the composite of fatal and non-fatal myocardial infarction, a 19% risk reduction of coronary revascularization, a 15% risk reduction of the MACE-3 composite, and a 13% risk reduction of the MACE-4 composite. Following the FDA’s review of the submission, it will notify the Company if the applications are deemed complete for review by mid-August 2023. The Company anticipates FDA approval of the sNDAs in the first half of 2024. “These submissions mark a pivotal achievement for Esperion as we seek to meaningfully expand the eligible patient populations for NEXLETOL and NEXLIZET,” said Sheldon Koenig, President and Chief Executive Officer of Esperion. “Since the announcement of the CLEAR Outcomes results, we’ve seen accelerating adoption of our practice-changing treatments as prescribers, patients and payers alike recognize NEXLETOL and NEXLIZET as the clear next step after statins, and value their potential to significantly reduce cardiovascular risk.” INDICATIONNEXLETOL and NEXLIZET are indicated as adjuncts to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. Limitations of Use: The effect of NEXLETOL and NEXLIZET on cardiovascular morbidity and mortality has not been determined. IMPORTANT SAFETY INFORMATIONContra...