Esperion Therapeutics Gets CHMP Positive Opinion for Cholesterol Medications

By Chris Wack

Esperion Therapeutics, along with partner Daiichi Sankyo Europe, said the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted positive opinions for label updates of bempedoic acid and the bempedoic acid/ezetimibe fixed dose combination.

The committee recommended these treatments to reduce low-density lipoprotein cholesterol and cardiovascular risk.

The existing label of bempedoic acid provides authorization for adults with primary hypercholesterolaemia or mixed dyslipidaemia. 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.

The existing label of bempedoic acid/ezetimibe FDC tablet provides authorization of its use in adults with primary hypercholesterolaemia or mixed dyslipidaemia. CHMP recommends an update of the bempedoic acid/ezetimibe label to amend its indication in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

March 22, 2024 11:34 ET (15:34 GMT)

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