Amgen (AMGN) has unveiled compelling new data showing its cholesterol-lowering drug Repatha significantly reduces the risk of death in high-risk cardiovascular patients.
The findings, announced on 31 August 2026, come from a pre-specified analysis of the Phase 3 VESALIUS-CV trial presented at the European Society of Cardiology Congress in Munich, Germany.
Results were simultaneously published in Circulation, one of the most widely read cardiovascular journals in the world.
The trial tracked more than 12,000 high-risk adults over a median of 4.6 years, focusing on patients who had never previously suffered a heart attack or stroke.
Repatha, known generically as evolocumab, reduced all-cause mortality by 20% when added to statins or other LDL-C-lowering treatments in this patient population.
Survival curves between the Repatha and control arms began separating at approximately 1.5 years into the study and continued to widen throughout the full follow-up period.
Amgen is positioning the data as the first Phase 3 evidence that a PCSK9 inhibitor can lower all-cause mortality in a primary-prevention population.
Paul Burton, M.D., Ph.D., chief medical officer at Amgen, said “earlier intensive lipid-lowering therapy with Repatha in these patients with high-risk diabetes, but without a cardiovascular event, profoundly protects them.”
Jay Bradner, Amgen’s head of R&D, AI and Data, called the mortality findings “practice-changing” given cardiovascular disease remains the leading global cause of death.
Bradner added that the results reinforce the importance of identifying high-risk patients early for aggressive and consistent LDL-C lowering treatment.
Two companion VESALIUS-REAL studies presented at the same ESC congress highlighted a persistent problem of undertreatment among patients with coronary artery disease and no prior cardiac event.
Those real-world studies found that patients frequently failed to reach recommended LDL-C levels due to low rates of treatment initiation, intensification, and monitoring by clinicians.
The European Commission approved an expanded indication for Repatha in August 2026, allowing its use in adults with established or high atherosclerotic cardiovascular disease risk to lower LDL-C.
That European approval followed an FDA label expansion in August 2025 covering adults at increased risk for major adverse cardiovascular events due to uncontrolled LDL-C levels.
The convergence of regulatory wins and strong Phase 3 mortality data marks a significant commercial and clinical turning point for Repatha and for Amgen’s broader cardiovascular portfolio.