Repatha Phase 3 Trial Hits Primary Endpoints
Amgen says the landmark Phase 3 VESALIUS-CV trial met its primary endpoints, demonstrating that Repatha (evolocumab) significantly reduced the risk of major adverse cardiovascular events in individuals without a prior history of heart attack or stroke. A company statement says the study involved over 12,000 high-risk patients.
Repatha is described as a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). It binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. It is indicated:
- to reduce the risk of major adverse cardiovascular events in adults at increased risk for these events; and
- as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol in specified adult and pediatric groups.