Positive Recommendation from EMA for Expanded Use of Repatha® to Decrease Risk of First Heart Attack or Stroke

Expanding Horizons in Cardiovascular Care with Repatha®

On July 30, 2026, Amgen (NASDAQ: AMGN) revealed significant news regarding its PCSK9 inhibitor, Repatha® (evolocumab). The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for broader usage of this innovative drug in adults with established atherosclerotic cardiovascular disease or those at heightened risk of such conditions. This endorsement signifies a monumental step towards improving cardiovascular health across Europe.

Significance of the Recommendation

This recommendation is backed by findings from the Phase III VESALIUS-CV trial, which involved more than 12,000 participants. This landmark study underscored Repatha's ability to significantly mitigate the risk of major cardiovascular events (MACE) such as heart attacks and strokes in high-risk adults who had no previous heart attacks or strokes. Notably, Repatha was shown to effectively lower LDL-C levels, complementing other risk factor management treatments.

Dr. Paul Burton, Amgen's Chief Medical Officer, highlighted an urgent need in Europe where many patients with elevated cardiovascular risk remain unable to achieve recommended LDL-C levels, despite existing lipid-lowering therapies. The CHMP's favorable opinion reflects the robust clinical data supporting Repatha, empowering Amgen to extend its reach to a larger segment of patients who could greatly benefit from this treatment.

A Closer Look at the Phase III VESALIUS-CV Trial

The VESALIUS-CV trial was a rigorous, randomized, double-blind study designed to assess the impact of LDL-C reduction via evolocumab on cardiovascular health. Results, published in the New England Journal of Medicine in November 2025, revealed that Repatha reduced the relative risk of coronary heart disease-related death, heart attacks, and ischemic strokes by 25%. In a broader composite endpoint that included any ischemic arterial revascularization, the risk was effectively reduced by 19%, and additionally, the drug led to a 36% reduction in the risk of heart attacks.

Participants treated with Repatha saw their median LDL-C levels drop significantly, illustrating the drug's effectiveness when added to existing therapies, such as statins or ezetimibe.

Addressing the Global Burden of Cardiovascular Diseases

Cardiovascular diseases remain the leading cause of death worldwide, illustrating the imperative need for effective prevention and treatment strategies. Recent studies revealed that over 99% of individuals experiencing a first cardiovascular event possess at least one modifiable risk factor, primarily high LDL-C levels. While guidelines from the European Society of Cardiology recommend aggressive LDL-C reduction, many high-risk patients still fall short of achieving their target levels due to the limitations of current therapies.

Repatha was initially approved in the EU in 2015 for treating adults and children with primary hypercholesterolemia or mixed dyslipidemia. Now, with this potential new indication pending final approval from the European Commission, Repatha could reshape the standard of care in cardiovascular management for eligible patients.

Amgen's Commitment to Cardiometabolic Innovation

Amgen has been at the forefront of cardiometabolic care for over 40 years, utilizing advanced biological and genetic insights to tackle the intertwined challenges of cardiovascular and metabolic diseases. Despite current therapies, many patients continue to experience significant residual cardiovascular risk due to persistently elevated LDL-C or genetic factors such as lipoprotein(a).

Beyond Repatha, Amgen is also advancing other potential therapies like MariTide and olpasiran designed to address various components of cardiometabolic health. As the healthcare landscape evolves, Amgen remains committed to innovating and expanding cardiovascular care to meet the needs of patients worldwide.

Conclusion

The EMA's endorsement of Repatha paves the way for expanded treatment opportunities in cardiovascular disease management. By promoting significant LDL-C reduction in high-risk individuals, Repatha not only has the potential to enhance patient outcomes but also to redefine the overall approach to cardiovascular risk management across Europe. With the European Commission’s final decision impending, the medical community is eagerly awaiting to see how Repatha will contribute to fighting one of the most pressing health concerns of our time.