Amgen says EU CHMP backs broader Repatha use to cut first heart attack, stroke risk

Amgen says the European Medicines Agency’s CHMP backed expanding Repatha’s EU use to adults with established atherosclerotic cardiovascular disease or high risk to cut LDL-C.

The opinion was supported by the Phase 3 VESALIUS-CV trial in more than 12,000 high-risk patients without prior heart attack or stroke.

The trial showed a 25% relative risk reduction in a composite of coronary death, myocardial infarction, or ischemic stroke versus placebo.

A European Commission decision is expected in the coming months.