On October 2, 2025, Amgen announced that its Phase 3 VESALIUS‑CV trial met both primary endpoints, demonstrating that Repatha (evolocumab) significantly reduced the risk of major adverse cardiovascular events in high‑risk patients who had never experienced a heart attack or stroke. The study enrolled more than 12,000 participants and followed them for a median of 4.5 years, showing a statistically significant reduction in the composite of coronary heart disease death, heart attack, ischemic stroke, and any ischemia‑driven arterial revascularization. No new safety signals were observed, confirming Repatha’s favorable benefit‑risk profile in this primary‑prevention population.
The VESALIUS‑CV results expand Repatha’s therapeutic indication to primary prevention, potentially opening access to tens of millions of patients who are at high cardiovascular risk but have not yet suffered an event. This milestone strengthens Amgen’s cardiovascular portfolio, supports future sales growth, and reinforces the company’s position as a leader in lipid‑lowering therapy.
The trial’s success underscores the clinical value of PCSK9 inhibition and positions Repatha as a cornerstone therapy for comprehensive lipid management, providing Amgen with a robust platform for continued growth in the cardiovascular market.
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