Repatha is the Only PCSK9 Inhibitor Proven to Significantly Reduce Risk of First Heart Attack and Stroke in Phase 3 Clinical Trial, Setting a New Benchmark in Cardiovascular Risk Reduction
Recommendation Based on the Landmark Phase 3 Global VESALIUS-Cardiovascular Trial of More Than 12,000 Patients
THOUSAND OAKS, Calif., July 29, 2026 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Repatha® (evolocumab) for adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors. The recommendation is based on results from the Phase 3 VESALIUS-CV trial, which demonstrated that Repatha significantly reduced the risk of major adverse cardiovascular events (MACE) in high-risk adults without a prior heart attack or stroke, when added to statins or other LDL-C-lowering treatments.
"There remains a significant unmet need in Europe, where many patients at high cardiovascular risk are unable to achieve recommended LDL-C levels despite available lipid-lowering therapies," said Paul Burton, M.D., Ph.D., chief medical officer at Amgen. "The CHMP's positive opinion reflects the strength of Repatha's clinical evidence and brings us one step closer to making Repatha available to more patients who may benefit from it. Repatha is the only PCSK9 inhibitor proven in a Phase 3 clinical trial to reduce the risk of a first major cardiovascular event. If approved by the European Commission, this expanded indication has the potential to redefine cardiovascular care for appropriate patients in Europe."
