CHMP opinion on variation to marketing authorisation of Nustendi (bempedoic acid + ezetimibe)- Daiichi Sankyo.

The CHMP adopted a new indication as follows: Cardiovascular disease; Nustendi is 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: a.in patients on a maximum tolerated dose of a statin and not adequately controlled with additional ezetimibe treatment or, b. in patients who are either statin-intolerant, or for whom a statin is contraindicated, and not adequately controlled with ezetimibe treatment or, c. in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.