Amgen’s Repatha meets primary Phase 3 endpoints in cardiovascular study

Amgen (AMGN) 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, or 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, or LDL-C, reducing therapy. Patients were followed for a median of approximately 4.5 years. Cardiovascular disease remains the leading cause of death worldwide. 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. Results show that the primary endpoints were both statistically and clinically significant. No new safety signals were observed.