Repatha - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

evolocumab

Opinion

On 23 July 2026, 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 Repatha. The marketing authorisation holder for this medicinal product is Amgen Europe B.V..

The CHMP adopted an extension to the existing indication as follows:

Established aAtherosclerotic cardiovascular disease

Repatha is indicated in adults with established or at high risk for 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.

For information, the full indications for Repatha will be as follows:

Hypercholesterolaemia and mixed dyslipidaemia

Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non‑familial) or mixed dyslipidaemia, and in paediatric patients aged 10 years and over with heterozygous familial hypercholesterolaemia, 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 paediatric patients aged 10 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.

Established aAtherosclerotic cardiovascular disease

Repatha is indicated in adults with established or at high risk for 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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold, removed text in strikethrough.

CHMP post-authorisation summary of positive opinion for Repatha (VR-00003222435)

Adopted Reference Number: EMADOC-1700519818-3316327

Key facts

• Name of medicine:
  Repatha
• EMA product number:
  EMEA/H/C/003766
• Active substance:
  Evolocumab
• International non-proprietary name (INN) or common name:
  evolocumab
• Therapeutic area (MeSH):
  • Dyslipidemias
  • Hypercholesterolemia
• Anatomical therapeutical chemical (ATC) code:
  C10AX13
• Marketing authorisation holder:
  Amgen Europe B.V.
• Date of opinion:
  23/07/2026
• Status:
  Positive