AMGEN announced that new data from its cardiovascular portfolio, including late-breaking results from the Phase 3 VESALIUS-CV clinical trial of Repatha®? (evolocumab), will be presented at the American Heart Association Scientific Sessions taking place November 7-10, 2025, in New Orleans, LA. Results from the landmark Phase 3 VESALI US-CV clinical trial of Rep Ag Ag.
Results from the landmark Phase3 VESALIUS- CV clinical trial of Repatha in patients at high cardiovascular risk without prior heart attack or stroke will be shared during the late-breaking scientific session, "Groundbreaking Trials in Cardiometabolic Therapeutics" on Saturday, November 8 at 9:10 a.m. CST (Abstract #LBS.01). These data build on previously presented results which demonstrated that the majority of patients did not initiate or intensify their lipid-lowering therapy despite being at high risk for cardiovascular events, underscoring a missed opportunity to improve lipid management and attain guidance-recommended LDL-C goals. The data to be presented at the 2025 American Heart Association Scientific Sessions extend the evidence for Repatha to a larger and more diverse ASCVD cohort, with a longer follow-up period in the real-world setting.
The clinical benefits and safety of Repatha have been studied for 15 years in 51 clinical trials with over 57,000 patients.3,4 Repatha is approved in 74 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the European Union.5 Applications in other countries are pending. The company look forward to studying this treatment further in the Phase 3 clinical trial OCEAN(a)-Outcomes, which is ongoing in patients with ASCVD and elevated Lp(a). All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd. or Kyowa Kirin Co.
Ltd.), the performance of Otezla®? (apremilast), acquisitions of ChemoCentryx Inc. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, integration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on business, outcomes, progress, and other such estimates and results. No forward-looking statement can be guaranteed and actual results may differ materially from those project.
Discovery or identifi cation of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The length of time that it takes for the company to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and expect similar variability in the future.
Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints have selected. The company develop product candidates internally and through licensing collaborations, partnerships and joint ventures. The results may be affected by ability to successfully market both new and existing products domestically and internationally and internationally.