The FDA approved new label expansions for bempedoic acid and the combination of bempedoic acid and ezetimibe, including indications for CV risk reduction and expanded LDL-c lowering for both primary and secondary prevention, regardless of statin use.

Broad new labels for bempedoic acid and the combination of bempedoic acid and ezetimibe were approved by the FDA. These new labels include indications for CV risk reduction, expanded LDL-c lowering for both primary and secondary prevention, use of bempedoic acid and bempedoic acid alone or in combination with statins and new indications for primary hyperlipidemia, alone or in combination with statin. These approved label expansions are based on data of the CLEAR Outcomes trial.

The Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion on the label expansions in Europe on March 21 2024, and the final determination by the EMA is expected in the second quarter of 2024.

In the CLEAR Outcomes trial, almost 14000 patients with, or at high risk, of CVD were enrolled and followed for a median duration of 3.4 years. The primary end point of MACE-4 (death from CV cause, nonfatal stroke, nonfatal MI or coronary revascularization) was reduced by 13% in the patients who received bempedoic acid compared to those who received placebo. Furthermore, relative risk reductions of 23% of fatal or nonfatal MI and 19% for coronary revascularization were observed, and 30% for MACE-4 in primary prevention patients.

Source: press release Esperion, March 22, 2024