Amgen wins EU backing for Repatha, targeting first-time heart attacks

Amgen received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) to expand Repatha’s label.

The recommendation supports using the drug to prevent first heart attacks or strokes in high-risk adults with atherosclerotic cardiovascular disease.

The endorsement follows the Phase 3 VESALIUS-CV trial.

This large-scale study included more than 12,000 patients.

Repatha significantly reduced major adverse cardiovascular events when added to standard lipid-lowering therapies.

If the European Commission grants final approval, Repatha will be the only PCSK9 inhibitor in Europe cleared for primary prevention in this group.

The commission expects to issue a final decision in the coming months.