Basic Information
Nustendi
Regulatory Information
EMEA/H/C/004959
March 27, 2020
January 30, 2020
7
December 2, 2024
Company Information
Germany
Zielstattstrasse 48 81379 Munich
Daiichi Sankyo Europe GmbH
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Hypercholesterolaemia and mixed dyslipidaemia Nustendi 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 statin 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: • 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.
Overview Summary
Nustendi is a medicine for lowering levels of cholesterol in the blood. It contains the active substances bempedoic acid and ezetimibe. The medicine is used to reduce blood cholesterol levels in adults with primary hypercholesterolaemia or mixed dyslipidaemia (conditions that cause high levels of fats, including cholesterol, in the blood). Patients taking the medicine are required to be on a low-fat diet. The medicine is also used to reduce the risk of heart problems in adults with, or at high risk for, problems affecting the heart and blood circulation, such as heart attack, stroke or other problems of the circulatory system caused by fatty deposits build up in the walls of the arteries (atherosclerosis). Nustendi is used in combination with a statin, or without a statin in patients who cannot take statins and who are already taking ezetimibe. In these patients, Nustendi replaces the ezetimibe they are already taking.