CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events

– Positive CHMP Opinions Are Based On The Analyses Of The Phase 3 Of The CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP Citrate Lyase (ACL)-Inhibiting Regimen) Outcomes Trial¹ –

– European Commission Decision On Label Update Authorization Applications Are Expected To Be Made In 1H 2024 –

ANN ARBOR, Mich. and MUNICH, Germany, March 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the label update of both bempedoic acid (marketed as NILEMDO▼) and the bempedoic acid / ezetimibe fixed dose combination (FDC) (marketed as NUSTENDI▼ ), recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.² The existing label of bempedoic acid (NILEMDO▼) provides authorisation for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:²

• 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, or²
• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.²

The CHMP recommended adopting an update to this label, with which bempedoic acid is also indicated 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:²

• in patients on a maximum tolerated dose of a statin with or without ezetimibe, or²
• alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated.²

The existing label of bempedoic acid / ezetimibe FDC tablet (NUSTENDI▼) provides authorisation of its use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:²

• in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe², or
• 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 alone²,
• in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin².