Amgen Builds Case for Repatha to Prevent Heart Disease With Landmark Late-Stage Data

Amgen announced on October 2, 2025, that Repatha (evolocumab) succeeded in a major late-stage trial (VESALIUS-CV), meeting primary endpoints in reducing the risk of cardiovascular events or death in people who have never had a heart attack or stroke, supporting its use in 'primary prevention'1 5 7.

Repatha is a PCSK9 inhibitor currently approved mainly for 'secondary prevention' (people with existing heart disease); these new results could significantly expand its use to adults at increased risk but without previous cardiovascular events1 4 7.

The trial found that adding Repatha to statin or other LDL-lowering therapy led to a significant reduction in composite cardiovascular events (about 15% in time to first event) and the drug was well tolerated3 5.

Based on VESALIUS-CV and other supporting data, the FDA in August 2025 expanded Repatha’s approved label to include adults at increased risk for major adverse cardiovascular events due to uncontrolled LDL cholesterol, removing the previous requirement for established cardiovascular disease diagnosis4 8 9.

Amgen has studied Repatha in more than 50 clinical trials with over 57,000 patients, demonstrating substantial LDL-C reductions and cardiovascular risk reduction, and this latest trial positions Repatha as the first PCSK9 inhibitor to show prevention of major cardiac events in high-risk adults without prior heart disease6 7.

The company presented additional safety data showing no decline in cognitive function associated with very low LDL cholesterol levels achieved by Repatha, reinforcing its long-term safety and efficacy profile2.