Key Takeaways:
Amgen's Repatha (evolocumab) cut the risk of death by 20 percent in high-risk adults without a prior heart attack or stroke, according to Phase 3 trial data presented at the European Society of Cardiology Congress in Munich.
"These data are practice-changing and reinforce the importance of identifying high-risk patients early and lowering LDL-C aggressively and consistently with Repatha," Jay Bradner, executive vice president of research and development at Amgen, said.
The VESALIUS-CV trial enrolled more than 12,000 patients with known atherosclerotic cardiovascular disease or high-risk diabetes who had no history of heart attack or stroke. Repatha reduced the risk of heart attack by 36 percent, with benefits appearing as early as six months into treatment. Median LDL-C fell to 45 mg/dL versus 109 mg/dL with placebo, and the mortality benefit emerged after roughly 1.5 years of treatment through a median follow-up of 4.6 years.
The findings, published simultaneously in Circulation, mark the first time a PCSK9 inhibitor has shown an all-cause mortality benefit in primary prevention. Repatha also reduced first, subsequent and total cardiovascular events, with the latter nearly doubling the number of events prevented, according to Marc S. Sabatine, chair of the TIMI Study Group at Mass General Brigham.
Repatha, first approved in 2015, is now indicated in 75 countries and has been used by about 9 million patients globally. The European Commission in August 2026 expanded its approval to adults with established or high-risk atherosclerotic cardiovascular disease based on the VESALIUS-CV results.
Amgen shares traded at $436.52 in pre-market, up 0.95 percent, after closing Friday at $432.42. The stock has ranged between $269.77 and $447.03 over the past year.
The mortality data could support a broader label and expand Repatha's addressable market beyond secondary prevention, strengthening Amgen's position against rival lipid-lowering therapies. Investors will watch for updated peak-sales guidance and further label expansion filings in the coming quarters.
This article is for informational purposes only and does not constitute investment advice.
