Nustendi (bempedoic acid;ezetimibe)
- Region
- 🇪🇺 EU
- Active substance
- bempedoic acid;ezetimibe
- Company
- Daiichi Sankyo Europe GmbH
- Status
- Authorised
- Therapeutic area
- Hypercholesterolemia; Dyslipidemias
- CHMP opinion
- Thu 30 Jan 2020
- EU approval
- Fri 27 Mar 2020
- Application
- EMEA/H/C/004959
- ATC
- C10B
- Official record
- www.ema.europa.eu
Indication
Hypercholesterolaemia and mixed dyslipidaemiaNustendi is indicated in 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,• in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statinCardiovascular diseaseNustendi 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:• in patients on a maximum tolerated dose of a statin and not adequately controlled with additional ezetimibe treatment or,• in patients who are either statin-intolerant, or for whom a statin is contraindicated, and not adequately controlled with ezetimibe treatment or, • in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.