CHMP recommends Nilemdo (bempedoic acid) to treat treatment of hypercholesterolemia and mixed dyslipidemia.- Daiichi Sankyo + Esperion

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 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 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, pain in extremity, and anaemia. The CHMP recommended granting the bempedoic acid 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 or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated. The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit. The European Commission will review the CHMP opinion and is expected to adopt a final decision in April 2020. The decision will be applicable to all 27 European Union member states plus the United Kingdom, Iceland, Norway and Liechtenstein.