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Adding Repatha to Standard Therapy of Statins or Other LDL-C Lowering Treatments Significantly Reduces Cardiovascular Events Compared with Standard Therapy Alone
Repatha is Now the First and Only PCSK9 Inhibitor to Demonstrate Significant Reduction of Cardiovascular Events as Both Primary and Secondary Prevention
THOUSAND OAKS, Calif., Oct. 2, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the Phase 3 VESALIUS-CV clinical trial met its dual primary endpoints demonstrating that Repatha® (evolocumab) significantly reduced the risk of major adverse cardiovascular events (MACE) in individuals without a prior history of heart attack or stroke. The landmark Phase 3 VESALIUS-CV trial enrolled over 12,000 high-risk patients, approximately 85% of whom were maintained on a high-intensity or moderate low-density lipoprotein cholesterol (LDL-C) reducing therapy. Patients were followed for a median of approximately 4.5 years.
Cardiovascular disease remains the leading cause of death worldwide. In 2017, the FOURIER study proved that Repatha reduced the risk of major cardiovascular (CV) events in people with established atherosclerotic disease (ASCVD) and a history of major cardiovascular events, such as heart attack or stroke. The VESALIUS-CV study was initiated to determine if Repatha could also reduce CV events in people without a history of heart attack or stroke. VESALIUS-CV now establishes that Repatha, added to statins or other LDL-C lowering treatments, significantly reduces cardiovascular events compared with standard therapy alone as primary prevention.
The VESALIUS-CV primary endpoints were time to first occurrence of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke as well as time to first occurrence of a composite of CHD death, heart attack, ischemic stroke or any ischemia-driven arterial revascularization. The results show that the primary endpoints were both statistically and clinically significant. No new safety signals were observed.
Posted In: AMGN
