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Amgen's Repatha®: A Landmark Achievement in Cardiovascular Health

In a groundbreaking study presented at the 2025 American Heart Association Scientific Sessions, Amgen revealed that its cholesterol-lowering drug, Repatha® (evolocumab), significantly reduces the risk of first major adverse cardiovascular events (MACE) by 25%. This finding comes from the Phase 3 VESALIUS-CV clinical trial, which involved over 12,000 participants with atherosclerosis or diabetes who had not previously experienced a heart attack or stroke.

Overview of the VESALIUS-CV Trial

The VESALIUS-CV trial is a robust, double-blind, randomized, placebo-controlled study focusing on the impact of Repatha on patients who are at high risk for cardiovascular issues but have no prior history of heart attacks or strokes. The trial assessed the effects of Repatha when combined with statins and other LDL-lowering medications. The results painted a compelling picture, highlighting the necessity of aggressive LDL-C management in preventing serious cardiovascular events.

Significant Findings

The trial revealed some impressive statistics:

• - 25% reduction in the risk of coronary heart disease death, heart attack, or ischemic stroke (3-P MACE).
• - 36% reduction in the risk of heart attacks overall.
• - A notable 19% reduction in broader cardiovascular outcomes, which include any ischemia-driven arterial revascularization (4-P MACE).

In the lipid sub-study cohort of patients, it was remarkable to note that the median achieved LDL-C was 45 mg/dL compared to 109 mg/dL in the placebo group, further showcasing the efficacy of adding Repatha to current treatment regimens.

Expert Insights

Dr. Jay Bradner, Executive Vice President of Research and Development at Amgen, remarked on the urgency of these findings: "The VESALIUS-CV results deliver clear and compelling evidence that intensive LDL-C lowering is critical to reducing cardiovascular risk... every patient facing elevated risk due to uncontrolled LDL-C should be considered for Repatha."

Dr. Marc S. Sabatine, Chair of the TIMI Study Group, expanded on the implications of Repatha beyond its previous benefits noted in the FOURIER trial. He emphasized that the current study also highlights the possibility of significant improvement for a much larger population living with atherosclerosis or diabetes without a history of cardiovascular events.

Additionally, key observations lent credence to the possible heart health benefits for nearly 60% of trial participants with diabetes, an often under-managed group when it comes to controlling LDL-C levels.

Dr. Osagie Ebekozien from the American Diabetes Association reiterated the importance of addressing cardiovascular disease, particularly as it stands as a leading cause of death for individuals with diabetes.

Safety and Side Effects

Notably, no significant safety concerns emerged from the study, with the tolerability of Repatha consistent with existing data. The side effects reported were primarily mild and similar to those seen in previous studies.

Availability and Future Directions

Since receiving its initial approval in 2015, Repatha has already helped over 6.7 million patients globally. Earlier this year, the FDA expanded its indications, allowing broader access for patients at increased cardiovascular risk due to uncontrolled LDL-C.

Patients can now obtain Repatha at a dramatically reduced price of $239 per month through Amgen’s direct-to-patient program, AmgenNow.

Conclusion

With cardiovascular diseases being a pressing health challenge worldwide, and the substantial statistics from the VESALIUS-CV trial validating the effectiveness of Repatha, it's evident that integrating such therapies could be pivotal in improving cardiovascular health outcomes. Amgen's ongoing commitment to innovation in treatment for cardiovascular diseases reflects a dedication to navigating this global health concern and reinforcing clinical practices that prioritize patient care and safety.