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Late-Breaking Phase 2 Data for Investigational Oral Factor XIa Inhibitor Milvexian Suggest Favorable Antithrombotic Profile Across a Wide Range of Doses

Published: 2021-11-15 16:18:00 ET

Milvexian demonstrated efficacy and no increase in bleeding across doses, with no major bleeds in the milvexian arms, when compared with enoxaparin, for postoperative venous thromboembolism (VTE) prevention in patients undergoing elective total knee replacement (TKR) surgery

AXIOMATIC-TKR is the first of two studies to read out from the Phase 2 milvexian program, which together will inform the design and dose regimens of the Phase 3 program

Data simultaneously published in The New England Journal of Medicine and presented at the American Heart Association Scientific Sessions 2021

Milvexian is being developed by The Bristol Myers Squibb-Janssen Collaboration

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson and Johnson (Janssen), today announced results from the Phase 2 AXIOMATIC-TKR study, which showed investigational oral milvexian reduced the risk of postoperative venous thromboembolism (VTE) in a dose dependent manner without increasing the risk of bleeding compared with enoxaparin in patients undergoing total knee replacement (TKR) surgery. These data were presented today at a Late-Breaking Science session at the American Heart Association (AHA) Scientific Sessions 2021 and simultaneously published in The New England Journal of Medicine (NEJM).

“This study establishes proof-of-principle for milvexian as a differentiated antithrombotic agent,” said Jeffrey Weitz, M.D., Professor of Medicine & Biochemistry and Biomedical Sciences at McMaster University and Executive Director of the Thrombosis and Atherosclerosis Research Institute. “Furthermore, the consistently low rates of bleeding across a 16-fold range of milvexian doses suggest that it has a wide therapeutic window, which opens the opportunity to explore milvexian across a broad range of patients, including those for whom factor Xa inhibitors are underutilized or not indicated.”

The trial met both of its pre-specified proof-of-principle requirements: the dose response for efficacy with twice-daily milvexian was significant (p

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
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