Bempedoic Acid Gains CV Risk Reduction Indication

The US Food and Drug Administration has approved expanded labeling for both bempedoic acid (Nexletol) and bempedoic acid/ezetimibe (Nexlizet) to include a new indication for cardiovascular risk reduction in both primary and secondary prevention settings, according to a Friday announcement from drugmaker Esperion.

Bempedoic acid, already approved to lower LDL cholesterol, can be used with or without statins to reduce the risk of MI and coronary revascularization in adults who are unable to take recommended statin therapy and who have a high risk for CVD or established disease. The FDA’s decision makes the agent the first nonstatin, LDL cholesterol-lowering medication indicated for use in the primary prevention of CVD.

The expanded labeling is supported by results from the CLEAR Outcomes study. Among high-risk patients unable to tolerate statin therapy, bempedoic acid lowered the risk of MACE by a relative 13%, driven primarily by reductions in MI and coronary revascularization.

Those findings also spurred positive recommendations to expand the drug’s labeling from the European Medicines Agency’s Committee for Medicinal Products for Human Use, also announced Friday. The European Commission still must review the opinions, with a final decision expected by the middle of the year.