EMA committee backs broader Repatha use before a first heart attack or stroke
The European Medicines Agency's CHMP adopted a positive opinion on July 29, 2026 for Repatha in adults with established or high-risk atherosclerotic cardiovascular disease, to reduce cardiovascular risk by lowering LDL cholesterol. The opinion rests on the Phase 3 VESALIUS-CV trial of more than 12,000 patients given Repatha on top of statins or other LDL-lowering treatment. A CHMP opinion is a recommendation, and the European Commission will make the final decision in the coming months.
- Positive CHMP opinion announced July 29, 2026
- VESALIUS-CV enrolled more than 12,000 patients
- 25% relative reduction in the 3-point major cardiovascular event composite
- Median LDL-C 45 mg/dL with Repatha versus 109 mg/dL with placebo in a lipid sub-study
- European Commission decision still pending
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Source
Amgen press release (July 29, 2026)Jul 29, 2026