News/Regulation/Jul 29, 2026

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
AMGN around the story · hourly
380.03387.11394.195:00 AM6:45 PM8:30 AM10:15 PM12:00 PM
Source
Amgen press release (July 29, 2026)
Jul 29, 2026
Read the original ↗