Evolocumab Reduces Risk of MACE for Patients Without Prior History of Heart Attack, Stroke

Evolocumab (Repatha) significantly reduced the risk of major adverse cardiovascular events (MACE) in individuals without a prior history of heart attack or stroke in the VESALIUS-CV (NCT03872401) clinical trial. The phase 3 study showed that evolocumab, when added to statins or low-density lipoprotein cholesterol (LDL-C) lowering agents, significantly reduces cardiovascular events compared with standard therapy alone.¹

"These results mark an important milestone in the fight against cardiovascular disease, the leading cause of death worldwide. The benefit across endpoints and established safety profile underscore Repatha's role as a cornerstone therapy in comprehensive lipid management," Jay Bradner, MD, executive vice president of research and development at Amgen, said in a news release.¹ "Repatha is known as a highly effective LDL-C lowering treatment and is now the first and only PCSK9 inhibitor shown to reduce cardiovascular events in high-risk adults without prior heart attack or stroke."

In the study, investigators included over 12,000 patients who were followed up for a median of 4.5 years. The study also expands on the FOURIER (NCT01764633) study, showing the drug can reduce MACE for patients with atherosclerotic disease and a history of cardiovascular events. New data expands on the findings, demonstrating that the drug can benefit patients without prior cardiovascular events. The coprimary outcomes included time to coronary heart disease death, myocardial infarction, or ischemic stroke and time to the previous outcome in addition to any ischemia-driven arterial stroke. Secondary end points included time to cardiovascular death, myocardial infarction, and ischemic stroke, as well as time to each disease outcome individually. Further, time to all causes of death was included as a secondary end point. Full results will be presented at the American Heart Association Scientific Sessions and submitted for publication in a peer-reviewed journal.^1,2

In August 2025, the FDA extended the approval of the drug to include patients at an increased risk for MACE due to uncontrolled LDL-C, which removed the prior requirement for patients who were already diagnosed with cardiovascular disease. Days after the announcement of the results for VESALIUS-CV, Amgen also announced the launch of AmgenNow, which is a new direct-to-patient program that will start with evolucumab. The drug will be available at a monthly price of $239, which is approximately 60% lower than the current list price in the US, according to the company.^3,4

"Amgen is committed to finding new ways to help patients benefit from our medicines," Murdo Gordon, executive vice president of global commercial operations at Amgen, said in a news release.⁴ "Repatha has already helped more than 5 million patients, and the AmgenNow program will make it easier for uninsured patients or those who choose to pay out-of-pocket to access treatment. This will allow even more Americans at increased risk of major adverse cardiovascular events to benefit from this effective medicine."

The program is open to all patients, including patients who are uninsured or have high-deductible health care plans, as well as patients who prefer to pay with cash or out of pocket.⁴

READ MORE: Cardiology Resource Center

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REFERENCES

1. Landmark phase 3 trial (VESALIUS-CV) meets primary endpoints in a cardiovascular primary prevention study of 12,000 patients. News release. Amgen. October 2, 2025. Accessed October 6, 2025. https://www.amgen.com/newsroom/press-releases/2025/10/landmark-phase-3-trial-vesaliuscv-meets-primary-endpoints-in-a-cardiovascular-primary-prevention-study-of-12000-patients

2. Effect of evolocumab in patients at high cardiovascular risk without prior myocardial infarction or stroke (VESALIUS-CV). ClinicalTrials.gov identification: NCT03872401. Updated October 6, 2025. Accessed October 6, 2025. https://www.clinicaltrials.gov/study/NCT03872401

3. Gallagher A. FDA expands approval of evolocumab to include patients at increased risk of MACE. Drug Topics. August 25, 2025. Accessed October 6, 2025. https://www.drugtopics.com/view/fda-expands-approval-of-evolocumab-to-include-patients-at-increased-risk-of-mace

4. Amgen makes Repatha available through AmgenNow, a direct-to-patient program in the US. News release. Amgen. October 6, 2025. Accessed October 6, 2025. https://www.amgen.com/newsroom/press-releases/2025/10/amgen-makes-repatha-available-through-amgennow-a-directtopatient-program-in-the-us