Basic Information
Repatha
Regulatory Information
EMEA/H/C/003766
July 17, 2015
May 20, 2015
26
September 6, 2024
Company Information
Netherlands
Minervum 7061 4817 ZK Breda
AMGEN EUROPE B.V.
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication **Hypercholesterolaemia and mixed dyslipidaemia** Repatha 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 or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. **Homozygous familial hypercholesterolaemia** Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies. **Established atherosclerotic cardiovascular disease** Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: - in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, - alone or in combination with other lipid-lowering therapies 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.
Overview Summary
Repatha is a medicine for lowering levels of fats in the blood. It is used to reduce blood fat levels in patients with primary hypercholesterolaemia (high blood cholesterol levels caused by a genetic abnormality), homozygous familial hypercholesterolaemia (a severe form of high blood cholesterol inherited from both parents) and mixed dyslipidaemia (abnormal levels of different fats, including cholesterol). It is also used to reduce the risk of heart problems in patients with atherosclerosis (thickened arterial walls) who have had a heart attack, stroke or other problems of the circulatory system (atherosclerotic heart disease). Repatha is used in combination with a statin or a statin and other fat-lowering medicines. Repatha can also be used without a statin in patients who cannot take statins. Some patients are required to be on a low-fat diet. Repatha contains the active substance evolocumab.