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$Esperion Therapeutics (ESPR.US)$ NEWS First-In-Class Choles...

NEWS
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
The European Commission has approved label updates for NILEMDO (bempedoic acid) and NUSTENDI (bempedoic acid/ezetimibe) to treat hypercholesterolemia and reduce cardiovascular risk. This approval is based on the positive results from the CLEAR Outcomes trial, making these the first and only LDL-C lowering treatments indicated for both primary and secondary prevention of cardiovascular events.
NILEMDO can lower cholesterol by up to 28% when added to statin therapy, while NUSTENDI can reduce LDL-C by 38% in high-risk patients. The Phase 3 CLEAR Outcomes trial involved 13,970 patients and showed a 13% reduction in major adverse cardiovascular events.
Despite existing treatments, up to 80% of patients do not achieve guideline-recommended LDL-C levels, highlighting the need for new options like NILEMDO and NUSTENDI. The approval aims to provide healthcare professionals with better tools to manage cardiovascular risk and reassure patients of effective treatment options.
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