FDA Expands Indications for Bempedoic Acid in CVD Prevention


The US FDA has expanded the indications for bempedoic acid and bempedoic acid plus ezetimibe combination to prevent heart attacks and cardiovascular procedures in primary- and secondary-prevention patients regardless of statin use. Bempedoic acid is indicated to reduce the risk for MI and coronary revascularization in adults unable to take recommended statin therapy with CVD, while the combination can reduce LDL-C in adults with primary hyperlipidemia. These expansions will make over 70 million patients eligible for these medications. The approvals eliminate the requirement for statin use. Data from the CLEAR Outcomes trial support these expanded indications.

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