First-In-Class Cholesterol-Lowering Treatment NILEMDO® (NEXLETOL® in the U.S.) and Its Combination with Ezetimibe, NUSTENDI® (NEXLIZET® in the U.S.), Approved In Europe To Treat Hypercholesterolemia and Significantly Reduce Cardiovascular Risk

Core Insights - The European Commission has approved label updates for NILEMDO (bempedoic acid) and NUSTENDI (bempedoic acid/ezetimibe fixed-dose combination) as treatments to reduce cardiovascular risk by lowering LDL-C levels, making bempedoic acid the first and only LDL-C lowering treatment indicated for both primary and secondary prevention of cardiovascular events [1][2][3] Group 1: Approval and Indications - The approval is based on positive results from the CLEAR Outcomes trial, which involved 13,970 patients across 1,250 sites in 32 countries, including 485 sites in Europe [6][17] - Bempedoic acid and its fixed-dose combination are indicated for adults with established or at high risk for atherosclerotic cardiovascular disease to lower LDL-C levels and reduce cardiovascular risk [2][15] Group 2: Market Need and Impact - Approximately one in seven people in Europe have high LDL-C levels, with cardiovascular disease being the leading cause of death, resulting in over 10,000 deaths daily [3] - Up to 80% of patients do not achieve guideline-recommended LDL-C goals despite treatment with statins, indicating a significant unmet medical need [3][4] Group 3: Efficacy of Treatments - Bempedoic acid can provide an additional cholesterol lowering of up to 28% on top of statin therapy compared to placebo [4] - The bempedoic acid/ezetimibe fixed-dose combination reduced LDL-C by 38% compared to placebo in high-risk patients already on maximum-tolerated statin therapy [4][15] Group 4: Statements from Company Executives - Company representatives expressed confidence that the new indication will help healthcare professionals better meet treatment needs and reassure patients about their cardiovascular risk management [5][6]