MUNICH, Germany -- August 31, 2026 -- Amgen's Repatha (evolocumab) reduced all-cause mortality by 20% in high-risk patients who had never suffered a heart attack or stroke, according to a pre-specified analysis of the Phase 3 VESALIUS-CV trial presented at the European Society of Cardiology Congress 2026 and published simultaneously in Circulation.
Trial data show mortality benefit emerging after 18 months of treatment
The analysis tracked more than 12,000 high-risk adults over a median of 4.6 years. Both overall deaths and cardiovascular deaths declined in the Repatha arm, with the survival curve separating at approximately 1.5 years and widening through follow-up. Amgen positions this as the first Phase 3 evidence that a PCSK9 inhibitor lowers all-cause mortality in a primary-prevention population.Second event prevention nearly doubles the clinical benefit, TIMI researcher says
Marc Sabatine, chair of the TIMI Study Group at Mass General Brigham, said evolocumab reduced not only first cardiovascular events but subsequent ones during the trial, with prevention of second events almost doubling total events avoided. He said the data support intensive LDL-C lowering to roughly 40 mg/dL to reduce both cardiovascular and non-cardiovascular deaths.Heart attack risk fell within six months, driven by fewer plaque ruptures
A separate VESALIUS-CV analysis found reduced heart attack risk as early as six months after treatment initiation, primarily from fewer type 1 infarctions caused by ruptured atherosclerotic plaque and fewer larger infarctions. Benefits held consistently across patient subgroups, reinforcing Amgen's push for earlier intervention rather than waiting for a first cardiac event.Lipid sub-study shows LDL-C dropped to median of 45 mg/dL versus 109 mg/dL on placebo
Adding Repatha to maximally tolerated statin and/or ezetimibe therapy cut LDL-C to a median 45 mg/dL among observed VESALIUS-CV patients, compared with 109 mg/dL in the placebo group. The full trial, published in the New England Journal of Medicine in November 2025, showed a 25% relative reduction in three-point MACE (coronary heart disease death, heart attack, ischemic stroke) and a 36% reduction in heart attack risk specifically.Global real-world data show most high-risk patients still miss LDL-C targets
Two companion VESALIUS-REAL studies presented at ESC found persistent undertreatment: patients with coronary artery disease and no prior heart attack or stroke frequently failed to reach recommended LDL-C levels due to low rates of treatment initiation, intensification and monitoring. A second analysis found women at high risk were less likely than men to receive intensive lipid-lowering therapy or hit LDL-C goals across multiple regions, pointing to a treatment gap independent of drug availability.Repatha now covers 75 countries after EU expanded its cardiovascular indication
The European Commission approved an expanded indication in August 2026 allowing Repatha's use in adults with established or high atherosclerotic cardiovascular disease risk to lower LDL-C, based on VESALIUS-CV results. That followed an FDA label expansion in August 2025 covering adults at increased risk for major adverse cardiovascular events due to uncontrolled LDL-C. Repatha is now approved in 75 countries, including the U.S., Japan, Canada and all 28 EU member states, with roughly 9 million patients treated globally since its 2015 launch.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, and said they reinforce identifying high-risk patients early for aggressive, consistent LDL-C lowering.
Amgen is advancing two additional cardiometabolic candidates, maridebart cafraglutide and olpasiran, alongside Repatha's expanded indication as it competes against biosimilar PCSK9 entrants and rival lipid-lowering therapies for share of a global primary-prevention market where treatment gaps remain wide despite 15 years of clinical evidence and 51 completed trials involving more than 57,000 patients.