Esperion reports CHMP issues positive opinions on Nilemdo and Nustendi

Daiichi Sankyo (DSNKY) and Esperion Therapeutics (ESPR) jointly announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted positive opinions for the label update of both bempedoic acid, marketed as Nilemdo, and the bempedoic acid / ezetimibe fixed dose combination, marketed as Nustendi, recommending their approval as treatments to reduce low-density lipoprotein cholesterol, or LDL-C, and cardiovascular risk. “We are thrilled with the positive CHMP opinion, which reflects the significant cardiovascular risk reduction benefit that the bempedoic acid global franchise brings to patients worldwide. This latest regulatory milestone further bolsters our efforts to work towards delivering innovative treatment options to manage cardiovascular risk for patients with elevated LDL-C,” said Sheldon Koenig, President and CEO, Esperion. The European Commission will review the CHMP opinions and is expected to deliver its final decision in the mid of the year 2024, the companies stated.