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ThromboGenics/BioInvent's long-acting anticoagulant TB-402 bests enoxaparin in Phase II

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Patients undergoing knee replacement surgery who were injected with TB-402 after surgery had a statistically significant reduction in venous thromboembolism compared to standard-of-care enoxaparin (Sanofi-Aventis' Lovenox) in a Phase II study, co-developers ThromboGenics and BioInvent reported July 9 at the International Congress on Thrombosis in Milan, Italy. TB-402 is a novel recombinant human antibody that partially inhibits Factor VIII, a component of the coagulation cascade. All 316 patients in the study received enoxaparin pre-operatively and then were randomized to receive one of three doses of TB-402, administered as a single intravenous bolus injection 18-24 hours after surgery, or enoxaparin as a subcutaneous injection every day for at least 10 days. Pooled data for the TB-402 arms showed 47 out of 218 pateints (22 percent) experienced VTE compared with 30 out of 77 patients (39 percent) on enoxaparin by days 7-11. The two anticoagulants had similar safety profiles

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