On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Nilemdo. The marketing authorisation holder for this medicinal product is Daiichi Sankyo Europe GmbH.
The CHMP adopted a new indication as follows:
Cardiovascular disease
Nilemdo 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.
For information, the full indications for Nilemdo will be as follows1:
Hypercholesterolaemia and mixed dyslipidaemia
Nilemdo 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 disease
Nilemdo 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.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1New text in bold
CHMP post-authorisation summary of positive opinion for Nilemdo (II-31)
English (EN) (160.62 KB - PDF)