Amgen's Repatha® Receives CHMP Endorsement for Broader Use to Prevent Initial Heart Attacks and Strokes

Amgen’s Pioneering Advancements in Cardiovascular Care

In a groundbreaking announcement, Amgen (NASDAQ: AMGN) shared that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for Repatha® (evolocumab). This new recommendation allows for broader use of Repatha among adults at significant risk of cardiovascular events, including first heart attacks and strokes. The endorsement marks a significant stride in managing cardiovascular risks, establishing a new standard for treatment and prevention.

Enhancing Patient Care with Clinical Evidence

Repatha is known as the only PCSK9 inhibitor proven in Phase 3 clinical studies to significantly reduce the risk of such critical cardiovascular issues. The positive opinion is based on the innovative global clinical trial, VESALIUS-CV, which involved over 12,000 high-risk patients. These results showcase that adding Repatha to standard therapy can drastically reduce the incidence of major cardiovascular events (MACE) in individuals yet to experience heart attacks or strokes.

Dr. Paul Burton, Amgen’s Chief Medical Officer, emphasized that there exists a considerable unmet need in Europe where many patients are unable to achieve recommended LDL-C levels, even with available therapies. He stated, “This positive CHMP opinion reflects the strength of clinical evidence around Repatha and brings us one step closer to making this treatment available to more patients who could benefit.” If approved by the European Commission, this extended indication has the potential to redefine cardiovascular care for suitable patients across Europe.

The Urgent Need for Effective Cardiac Interventions

Globally, cardiovascular diseases remain the leading cause of death, and many patients experience their first cardiovascular events despite having at least one modifiable risk factor. High LDL cholesterol levels significantly contribute to these risks. Despite guidelines from the European Society of Cardiology (ESC) advocating aggressive LDL-C reduction to mitigate cardiovascular risks, many high-risk patients fail to reach their target LDL-C levels even with available lipid-lowering therapies. This situation underscores the necessity for effective treatments like Repatha that can facilitate achieving these benchmarks.

Initially approved in the European Union in 2015 for adults and children with primary hypercholesterolemia or mixed dyslipidemia, as well as for reducing cardiovascular risk in patients with a history of atherosclerotic cardiovascular disease (ASCVD), Repatha has continually been at the forefront of cardiovascular treatment innovation. The European Commission's final decision regarding this new recommendation is anticipated in the coming months.

Investigating the VESALIUS-CV Study

The VESALIUS-CV study is a landmark Phase III double-blind, randomized clinical trial designed to assess the impact of LDL-C reduction by evolocumab on MACE incidence among high-risk adults without a history of myocardial infarction or stroke. Its results, published in the New England Journal of Medicine in November 2025, demonstrated a 25% relative reduction in the risk of composite outcomes encompassing ischemic heart disease mortality, myocardial infarction, and ischemic stroke (3-P MACE), alongside a 19% reduction in a broader composite measure including any revascularization due to ischemia (4-P MACE). Notably, evolocumab also led to a 36% reduction in myocardial infarction risk, establishing its robust clinical benefits across observed cardiovascular risk parameters.

Amgen's Commitment to Cardiovascular Innovation

Amgen is passionately committed to advancing cardiovascular medicine through cutting-edge scientific research grounded in human biology. The company’s innovative approaches are particularly aimed at addressing the intertwined cardiovascular and metabolic diseases that lead to severe outcomes, including mortality.

Despite significant progress in lipid management and metabolic treatments, residual cardiovascular risk persists due to factors like elevated LDL-C levels and conditions related to obesity. With over 40 years of advanced research and genetic insights, Amgen is well-positioned to deliver innovative solutions, including potentially transformative therapies like MariTide and olpasiran to meet cardiovascular and metabolic care needs.

About Repatha

Repatha functions as a human monoclonal antibody that inhibits the proprotein convertase subtilisin/kexin type 9 (PCSK9). By binding to PCSK9, Repatha prevents it from degrading low-density lipoprotein receptors (LDLR), allowing for more LDLRs on liver cells to eliminate LDL from the bloodstream, thus reducing LDL-C levels.

Repatha is among the most extensively studied PCSK9 inhibitors, with its efficacy and safety demonstrated through comprehensive clinical trials that have evaluated diverse patient groups over 15 years. With over 10 million patients worldwide utilizing Repatha since its initial approval, the treatment continues to evolve, and recent approvals have expanded its indications further.

In closing, the latest endorsement by CHMP is a crucial milestone that could alter cardiovascular treatment paradigms in Europe and improve health outcomes for patients at elevated risk. Amgen's relentless pursuit of innovative cardiovascular solutions showcases its dedication to improving patient care and health standards worldwide.