Esperion applies for expanded indication with EMA for NILEMDO, NUSTENDI

Esperion announced that the application was filed for a Type II 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 variation application in Europe marks the culmination of Esperion’s landmark Cholesterol Lowering via bempedoic acid, an ACL-Inhibiting Regimen 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.