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REPATHA® APPROVED TO REDUCE CARDIOVASCULAR RISK1

Therapeutic indications1

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 of the SmPC.

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.

*
25% RRR reported as the key secondary endpoint: composite of cardiovascular death, MI or stroke. HR: 0.75; 95% CI: 0.62-0.91; p=0.003. ARR: 3.2%; 95% CI: 1.2-5.2.
ACS = Acute coronary syndrome; ARR = Absolute risk reduction; CV = Cardiovascular; EAS = European Atherosclerosis Society; ESC = European Society of Cardiology; EVOPACS = EVOlocumab for Early Reduction of LDL-cholesterol Levels in Patients With Acute Coronary Syndromes; LDL-C = Low-density lipoprotein cholesterol; MI = Myocardial infarction; PCSK9 = Protein convertase subtilisin/kexin type 9; RRR = Relative risk reduction; SmPC = Summary of Product Characteristics.
  1. Repatha® (evolocumab) Summary of Product Characteristics. Last revised: 31 March 2021.
  2. Gencer B, et al. JAMA Cardiol. 2020;5(8):1-6.

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