THOUSAND OAKS, Calif., July 29, 2026
Amgen has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending an expanded indication for Repatha® (evolocumab) to reduce cardiovascular risk in adults with established or high-risk atherosclerotic cardiovascular disease (ASCVD) before the occurrence of a first heart attack or stroke. The recommendation is based on results from the landmark Phase 3 VESALIUS-CV trial, which enrolled more than 12,000 patients and demonstrated that Repatha significantly reduced the risk of major adverse cardiovascular events (MACE) when added to statins or other LDL cholesterol-lowering therapies. If approved by the European Commission, the expanded indication could broaden access to one of the world’s most extensively studied PCSK9 inhibitors, offering earlier intervention for patients at elevated cardiovascular risk and reinforcing the role of aggressive LDL-C reduction in preventive cardiovascular medicine.
Positive CHMP Opinion Supports Earlier Cardiovascular Risk Reduction
The CHMP recommendation marks a significant regulatory milestone for Repatha, supporting its use in adults with established or high-risk ASCVD to reduce cardiovascular risk before the onset of a first heart attack or stroke. The recommendation follows strong evidence from the global Phase 3 VESALIUS-CV trial, which evaluated the benefits of intensive LDL cholesterol lowering in patients without a previous cardiovascular event. According to the study, Repatha became the only PCSK9 inhibitor to demonstrate a significant reduction in the risk of a first major cardiovascular event in a Phase 3 clinical trial, setting a new benchmark for primary cardiovascular prevention. The positive opinion also reflects the growing recognition that many high-risk patients continue to have elevated LDL cholesterol despite receiving standard lipid-lowering therapies, highlighting the need for additional treatment options capable of delivering more effective cardiovascular protection. If the European Commission grants final approval, the expanded indication could significantly increase patient access across Europe.
Phase 3 VESALIUS-CV Trial Demonstrates Significant Clinical Benefit
The regulatory recommendation is supported by findings from the Phase 3 VESALIUS-CV trial, a randomized, double-blind, placebo-controlled global study involving more than 12,000 patients with high cardiovascular risk who had no prior history of heart attack or stroke. Participants received Repatha alongside optimized lipid-lowering therapy, including maximally tolerated statins and/or ezetimibe. Results demonstrated a 25% relative reduction in the composite risk of coronary heart disease death, heart attack, or ischemic stroke and a 19% reduction in a broader composite cardiovascular endpoint that included ischemia-driven arterial revascularization. The study also reported a 36% reduction in heart attack risk, while patients receiving Repatha achieved substantially lower LDL cholesterol levels compared with placebo. These findings further strengthen the clinical evidence supporting early LDL-C lowering as a strategy to reduce cardiovascular events before irreversible disease progression occurs.
Advertisement
Expanded Indication Could Redefine Preventive Cardiology
Cardiovascular disease remains the leading cause of death worldwide, and clinical evidence indicates that the overwhelming majority of individuals experiencing a first cardiovascular event have at least one modifiable risk factor, including elevated LDL cholesterol. Although current European guidelines recommend intensive lipid management for high-risk individuals, many patients fail to achieve recommended LDL-C targets using conventional therapies alone. If the European Commission approves the CHMP recommendation, Repatha could become an important treatment option for reducing cardiovascular risk earlier in the disease process, helping physicians intervene before life-threatening heart attacks or strokes occur. The announcement also reinforces Amgen’s ongoing commitment to advancing innovative cardiometabolic therapies, with Repatha continuing to play a central role in the company’s cardiovascular portfolio while supporting future advances in preventive cardiovascular care.
Source: Amgen press release
