CHMP recommends Nustendi (bempedoic acid / ezetimibe fixed dose combination) for the treatment of hypercholesterolemia and mixed dyslipidemia. Esperion + Daiichi Sankyo

Esperion announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the MAA for the bempedoic acid / ezetimibe fixed dose combination tablet, recommending approval for the treatment of hypercholesterolemia and mixed dyslipidemia. The positive CHMP opinion was achieved with no Oral Explanation as the Rapporteurs found there were no substantive issues that needed to be discussed with the CHMP at the time of the vote.

The benefits with the bempedoic acid / ezetimibe fixed dose combination tablet are its ability to reduce levels of LDL-C, but also non-high density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (apo B), and total cholesterol (TC) in patients with hypercholesterolaemia or mixed dyslipidaemia when administered alone and in combination with other lipid-modifying medicinal products.

The most common side effects are hyperuricaemia and constipation. The CHMP recommended granting the bempedoic acid / ezetimibe fixed dose combination tablet marketing authorisation for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe, alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone, or in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.

The European Commission will review the CHMP opinion and is expected to adopt a final decision in April 2020.