European Medicines Agency's CHMP recommends approval of bempedoic acid and its combination with ezetimibe for LDL-C reduction and cardiovascular risk.
The European Medicines Agency's CHMP has recommended the approval of bempedoic acid and a combination of bempedoic acid and ezetimibe for reducing low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk. The recommendations are based on the Phase 3 CLEAR Outcomes trial, which showed a 13% reduction in major adverse cardiovascular events (MACE-4) among 13,970 patients. The expanded indications will make bempedoic acid the first non-statin drug indicated for primary prevention patients who are statin-intolerant or at high risk of a cardiovascular event.
March 22, 2024
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