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15 de nov. de 2021 · Milvexian significantly reduced the incidence of venous thromboembolism after elective knee arthroplasty in a dose-dependent manner with both twice-daily and once-daily regimens.
- Jeffrey I Weitz, John Strony, Walter Ageno, David Gailani, Elaine M Hylek, Michael R Lassen, Kenneth...
- 2021
- Background
- Methods
- Results
- Conclusions
Factor XIa inhibitors for the prevention and treatment of venous and arterial thromboembolism may be more effective and result in less bleeding than conventional anticoagulants. Additional data are needed regarding the efficacy and safety of milvexian, an oral factor XIa inhibitor.
In this parallel-group, phase 2 trial, we randomly assigned 1242 patients undergoing knee arthroplasty to receive one of seven postoperative regimens of milvexian (25 mg, 50 mg, 100 mg, or 200 mg twice daily or 25 mg, 50 mg, or 200 mg once daily) or enoxaparin (40 mg once daily). The primary efficacy outcome was venous thromboembolism (which was a ...
Among the patients receiving milvexian twice daily, venous thromboembolism developed in 27 of 129 (21%) taking 25 mg, in 14 of 124 (11%) taking 50 mg, in 12 of 134 (9%) taking 100 mg, and in 10 of 131 (8%) taking 200 mg. Among those receiving milvexian once daily, venous thromboembolism developed in 7 of 28 (25%) taking 25 mg, in 30 of 127 (24%) ta...
Postoperative factor XIa inhibition with oral milvexian in patients undergoing knee arthroplasty was effective for the prevention of venous thromboembolism and was associated with a low risk of bleeding. (Funded by Bristol Myers Squibb and Janssen Research and Development; AXIOMATIC-TKR ClinicalTrials.gov number, NCT03891524. opens in new tab.)
- Jeffrey I Weitz, John Strony, Walter Ageno, David Gailani, Elaine M Hylek, Michael R Lassen, Kenneth...
- 2021
Milvexian (BMS-986177/JNJ-70033093) is a small molecule, active-site inhibitor of factor XIa (FXIa) being developed to prevent and treat thrombotic events. The safety, tolerability, pharmacokinetics (PKs), and pharmacodynamics (PDs) of milvexian were assessed in a two-part, double-blind, placebo-con ….
15 de nov. de 2021 · Milvexian is a potential new antithrombotic drug that inhibits factor XIa, a key protein in blood clotting. Phase 2 data show that milvexian reduces VTE risk and bleeding compared with enoxaparin in TKR surgery patients.
Milvexian is a high‐affinity inhibitor of FXIa in cynomolgus monkeys, rabbits, and dogs. Milvexian exhibits ≥100‐fold selectivity for FXIa over activated plasma kallikrein in cynomolgus monkeys and rabbits, species used in toxicologic and pharmacologic studies, respectively.
Synfacts 2021, 1395. https://doi.org/10.1055/s-0041-1737130. Download PDF. Factor XIa (FXIa) is an enzyme in the coagulation cascade thought to amplify thrombin generation but has a limited role in hemostasis. From preclinical models and human genetics, an inhibitor of FX...
25 de mar. de 2022 · Milvexian was generally safe and well tolerated. The pharmacokinetic and pharmacodynamic profile of milvexian demonstrates suitability for further clinical development in Japanese participants.
