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Amgen's Landmark Repatha Results to be Unveiled at AHA 2025

Amgen, a leader in biotechnology, has announced exciting findings from their Phase 3 VESALIUS-CV trial of Repatha® (evolocumab) that will take center stage at the upcoming American Heart Association (AHA) Scientific Sessions 2025, occurring in New Orleans from November 7 to 10.

The late-breaking results to be shared on November 8 demonstrate that Repatha met its dual primary endpoints, showcasing its ability to meaningfully reduce the risk of major adverse cardiovascular events (MACE) among high-risk patients, specifically those who have never experienced a heart attack or stroke. This positions Repatha as the first and only PCSK9 inhibitor to achieve such an outcome in this patient population, marking a significant milestone in cardiovascular treatment.

Dr. Jay Bradner, Amgen's Executive Vice President of Research and Development, expressed the importance of these findings, stating, “With powerful new data that reinforce the importance of early intervention and maintaining low LDLC levels, Repatha surpasses traditional lipid-lowering therapies in preventing initial heart attacks and strokes.”

This groundbreaking research highlights Amgen's commitment to advancing cardiovascular health through innovative strategies and comprehensive treatment plans that cater to diverse risk profiles. The reported findings will provide insights into how Repatha can be integrated into broader patient care frameworks to manage cardiovascular diseases effectively.

Consolidating Real-World Evidence

Complementing the findings from the VESALIUS-CV trial, Amgen will also present data from the VESALIUS-REAL global observational study. This extensive study spans 11 countries and includes over 1.1 million patients, offering critical insights into lipid management and the rates of major cardiovascular events in high-risk populations.

Previous data indicated that many patients at high risk for cardiovascular events do not initiate or intensify their lipid-lowering therapies, revealing a substantial gap in achieving optimal treatment goals. The new findings underscore the necessity for proactive management in these patients to reduce MACE effectively.

Further, the REPATHA-CE trial results will illustrate the long-term efficacy of Repatha in patients with established atherosclerotic cardiovascular disease (ASCVD), particularly in reducing MACE rates in clinical practice. The data is expected to extend previous findings from the FOURIER trial, which already established the benefits of Repatha in reducing MACE in patients with a history of such events.

Addressing the Global Burden of Cardiovascular Disease

Cardiovascular disease (CVD) remains a pressing global health challenge. The combination of high cholesterol levels alongside other risk factors such as obesity and hypertension requires innovative solutions for prevention and management. Amgen is leading the charge in creating a thorough and effective approach to tackle these intertwined issues through advanced research and development initiatives that prioritize patient outcomes.

Repatha itself is a human monoclonal antibody designed to inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9), facilitating the clearance of low-density lipoprotein (LDL) cholesterol from the bloodstream. With more than 57,000 patients enrolled across 51 clinical trials, Repatha has gained approval in 74 countries due to its demonstrated safety and efficacy.

The Future of Cardiovascular Innovation

Amgen's extensive research portfolio continues to evolve, pushing the boundaries of treatment methodologies for CVD and reaffirming its commitment to enhancing patient care. As the company prepares to share groundbreaking results at the AHA Scientific Sessions, the emphasis is on the collective effort needed to combat cardiovascular diseases effectively.

In conclusion, the forthcoming presentation of VESALIUS-CV results and real-world data serves as a testament to Amgen's dedication to understanding and innovating cardiovascular treatment and showcases Repatha's role in transforming approaches to managing high-risk patient populations. The implications of these results have the potential to redefine treatment paradigms and improve outcomes for countless individuals suffering from cardiovascular conditions.