Late-Breaking Phase 2 Data for Investigational Oral Factor XIa Inhibitor Milvexian Suggest Favorable Antithrombotic Profile Across a Wide Range of Doses
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.[i] “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<0.001), and the 12% rate of VTE with combined twice-daily doses of milvexian was significantly lower (p<0.0001) than the prespecified benchmark rate of 30%. At daily doses of at least 100 mg, the rates of VTE with milvexian were significantly lower than with enoxaparin (p≤0.014).
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*Primary efficacy outcome defined as the composite of asymptomatic deep-vein thrombosis (detected by mandatory unilateral venography performed 10 to 14 days after surgery), confirmed symptomatic venous thromboembolism (symptomatic deep-vein thrombosis of the leg or nonfatal pulmonary embolism), or death.† Safety outcomes were assessed in the safety population, which consisted of all patients who recei...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
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