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# Repatha Phase 3 Trial Hits Primary Endpoints
- URL: https://www.fdaweb.com/repatha-phase-3-trial-hits-primary-endpoints/
- Published: 2025-10-02T12:00:00.000Z
- Updated: 2026-09-14T15:23:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159974

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](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?ref=fdaweb.com) 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.