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Amgen says EMA panel backs Repatha label expansion after phase 3 study

Amgen says EMA panel backs Repatha label expansion after phase 3 study

The CHMP recommendation covers adults with established or high risk of atherosclerotic cardiovascular disease and is based on the VESALIUS-CV trial of more than 12,000 patients.

Fact Check
Amgen's official newsroom press release confirms the EMA's CHMP adopted a positive opinion recommending broader use of Repatha (evolocumab) in adults with established or high risk of atherosclerotic cardiovascular disease, based on the Phase 3 VESALIUS-CV trial of more than 12,000 patients. This matches every element of the claim. Independent trade press (Pharmaceutical-technology) and PR Newswire distributions corroborate the same facts, including the trial size and patient population.
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Summary

Amgen said the EMA’s CHMP (European Medicines Agency committee on human medicines) issued a positive opinion on expanding Repatha for adults with established or high risk of atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C as an adjunct to correction of other risk factors. The recommendation is based on the phase 3 VESALIUS-CV trial, which showed Repatha significantly reduced major adverse cardiovascular events in high-risk adults without a previous heart attack or stroke when added to statins or other LDL-C-lowering therapy. Amgen said Repatha is the only PCSK9 inhibitor (LDL-lowering drug class) shown in a phase 3 trial to reduce the risk of a first major cardiovascular event. The company said the European Commission is expected to make a final decision in the coming months.

Terms & Concepts
  • PCSK9 inhibitor: A drug that lowers LDL cholesterol by blocking PCSK9.
  • LDL-C: Low-density lipoprotein cholesterol, often called bad cholesterol.
  • MACE: Major adverse cardiovascular events such as heart attack or stroke.