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Esperion Announces Submission of Application for Expanded Indication with the European Medicines Agency (EMA) for NILEMDO® (bempedoic acid) Tablet and NUSTENDI® (bempedoic acid and ezetimibe) Tablet
– Seeking inclusion of CV risk reduction indications in Europe – – Anticipated approvals in Europe in the first half of 2024 – ANN ARBOR, Mich., June 28, 2023
About this update from Esperion Therapeutics, Inc.
[{"type":"text","content":"– Seeking inclusion of CV risk reduction indications in Europe – – Anticipated approvals in Europe in the first half of 2024 – ANN ARBOR, Mich., June 28, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that the application was filed for a Type II(a) variation with the European Medicines Agency (EMA) for the Company’s oral non-statin products marketed as NILEMDO and NUSTENDI in Europe. The application asks EMA to approve both NILEMDO and NUSTENDI to reduce cardiovascular risk in patients with or at high risk for atherosclerotic cardiovascular disease. The Type II(a) variation application in Europe marks the culmination of Esperion’s landmark Cholesterol Lowering via bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial in which NILEMDO demonstrated significant cardiovascular risk reduction across a range of important clinical events 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. The Company anticipates the first action from EMA in October 2023, with EMA approval in the first half of 2024. NILEMDO and NUSTENDI are available in the United States as NEXLETOL® (bempedoic acid) tablet and NEXLIZET® (bempedoic acid and ezetimibe) tablet. Last month, Esperion submitted sNDAs to the Food & Drug Administration (FDA) to expand the indication in the United States to add the use of NEXLETOL and NEXLIZET for cardiovascular risk reduction. The Company anticipates FDA approval of the sNDAs in the first half of 2024. “Following our sNDA submissions in the U.S. last month, our EMA submission marks yet another important achievement for Esperion as we continue to significantly expand the eligible patient populations indicated for our drugs globally,” said Sheldon Koenig, President and Chief Executive Officer of Esperion. “The accelerating adoption of our practice-changing treatments around the world is evidence that prescribers, patients and payers alike recognize our oral products as the clear next step after statins, and value their potential to significantly reduce cardiovascular risk. We look forward to making our treatments increasingly available to patients by virtue ...