Overview
- Topline data from the VESALIUS‑CV study show evolocumab reduced major cardiovascular events in adults without prior heart attack or stroke, according to Amgen.
- More than 12,000 high‑risk patients with atherosclerosis or diabetes on background lipid therapy were randomized to Repatha or placebo.
- Evolocumab met two primary endpoints covering time to first coronary heart disease death, heart attack or ischemic stroke, and a broader composite including ischemia‑driven revascularization.
- Participants were followed for a median of about 4.5 years, with roughly 85% on moderate or high‑intensity LDL‑C therapy throughout the trial.
- Amgen called the benefits statistically and clinically significant but withheld effect sizes until the AHA presentation, framing the results as supporting an August FDA label expansion as Repatha nears 2030 patent expiry and faces rivals including Merck’s oral PCSK9, Praluent and Leqvio.