Overview

• Amgen reported that the Vesalius-CV study met its co-primary endpoints, cutting a composite of coronary heart disease death, heart attack and ischemic stroke in people without prior events.
• The Phase III trial enrolled about 12,000 high-risk adults with atherosclerosis or diabetes and elevated LDL cholesterol, allowed background lipid-lowering therapy, and followed participants for a median of roughly 4.5 years.
• Effect sizes and detailed safety data were not disclosed, with the full results set for presentation Nov. 8 at the American Heart Association Scientific Sessions and subsequent journal publication.
• The readout follows an FDA decision in August to expand Repatha’s U.S. label for adults at increased risk of major adverse cardiovascular events due to uncontrolled LDL-C, a move the company says these data support.
• Analysts expect the results could broaden prescribing even as Repatha faces competition from an oral PCSK9 candidate from Merck, other LDL-C–lowering therapies and potential biosimilars around 2030.