Esperion, Daiichi announce EC approved label update for NILEMDO, NUSTENDI

Daiichi Sankyo Europe (DSNKY) and Esperion Therapeutics (ESPR) jointly announced that the European Commission, EC, has approved the label update of both NILEMDO and NUSTENDI, as treatments for hypercholesterolemia and to reduce the risk of adverse cardiovascular events. The EC’s decisions to update the labels of bempedoic acid and bempedoic acid / ezetimibe FDC are based on the positive CLEAR Outcomes trial results and makes them the first and only LDL-C lowering treatments indicated for primary and secondary prevention of cardiovascular events. The EC decisions follow the previous CHMP opinions received in March this year, and approved bempedoic acid and its fixed-dose combination for use in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors.