Nilemdo (bempedoic acid)
- Region
- 🇪🇺 EU
- Active substance
- bempedoic acid
- Company
- Daiichi Sankyo Europe GmbH
- Status
- Authorised
- Therapeutic area
- Hypercholesterolemia; Dyslipidemias
- CHMP opinion
- Thu 30 Jan 2020
- EU approval
- Wed 01 Apr 2020
- Application
- EMEA/H/C/004958
- ATC
- C10AX
- Official record
- www.ema.europa.eu
Indication
Hypercholesterolaemia and mixed dyslipidaemiaNilemdo 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 or statin with other lipid-lowering therapies in patients unable to reach LDL C goals with the maximum tolerated dose of a statin (see sections 4.2, 4.3, and 4.4) or,• alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.Cardiovascular diseaseNilemdo 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 with or without ezetimibe or,• alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated.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.
Same substance in other markets
- 🇪🇺 Nustendi Authorised · Daiichi Sankyo Europe GmbH
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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.