BiotechTracker - Exanta Continues to Impress
June 24, 2003,A major study demonstrates that AstraZeneca’s (NYSE: AZN) Exanta (ximelagatran) is not inferior to, but is more convenient than, enoxaparin/warfarin for the prevention of recurrent venous thromboembolism (VTE) in patients with acute deep vein thrombosis (DVT) with or without pulmonary embolism (PE). Major bleeding and mortality rates were favorable. THRIVE Treatment Study investigators, led by M.V. Huisman, will present the ambitious study on July 14, 2003 at the XIX Congress of the International Society on Thrombosis and Haemostasis.  European regulatory submission, expected in the fourth quarter of this year, continues to be supported by data generated out of multiple Exanta trial programs. Exanta has consistently generated high-powered data supporting approval, in both Europe and the U.S., as an improvement to Bristol Myers Squibb’s (NYSE: BMY) Coumadin and other effective but clinically cumbersome warfarin formulations.  This investigation is important because the current standard of care for VTE requires intravenous unfractionated heparin or subcutaneous low-molecular-weight heparin such as Lovenox (an enoxaparin formulation from Aventis [NYSE: AVE]) followed by maintenance on oral vitamin K antagonists such as Coumadin. Oral vitamin K antagonists require frequent coagulation monitoring with blood tests and frequent dose adjustments. On the other hand, Exanta’s pharmacological profile is such that neither multiple blood tests nor dose adjustments are typically required. The observation that Exanta use is as efficacious as current therapies while maintaining a superior convenience profile appeals to multiple physician, patient, and medical payor and provider concerns.  2,491 study subjects with acute DVT participated in this randomized, double-blind, investigation. 37% of the subjects experienced confirmed PEs. They were randomized to receive either twice-daily Exanta 36 mg for 6 months, or twice daily enoxaparin 1 mg/kg for a minimum of 5 days followed by warfarin (target INR [blood anticoagulation level] 2.0-3.0) for 6 months. Sham INR values were generated for participants in the Exanta arm.  1,241 patients received Exanta and 1,250 patients received enoxaparin/warfarin. The table compares clinical endpoint outcomes between the two treatment groups, verifying Exanta noninferiority. It should be noted that the cumulative risk of ALAT elevations (> 3 times the upper limit of normal) was 9.8% for Exanta recipients and only 2.0% enoxaparin/warfarin recipients. These liver function test elevations spontaneously decreased as treatment either continued or was discontinued and, as has been the case in previous Exanta studies, was not associated with the development of symptoms of liver impairment.   Event Exanta n (%*) Enoxaparin/Warfarin n (%*) Absolute difference Exanta: Enoxaparin/Warfarin %* (95% Cl) Recurrent VTE (ITT) 26 (2.1%) 24 (2.0%) +0.2%** (-1.0%; + 1.3%) Recurrent VTE (OT) 23 (2.0%) 17 (1.5%) +0.5% (-0.6%; + 1.6%) All-cause mortality (ITT) 28 (2.3%) 42 (3.4%) -1.0%** (-2.4%; +0.2%) Major bleeding (OT) 14 (1.3%) 25 (2.2%) -0.9% (-2.0%; +0.2%) Recurrent VTE and/or major bleeding (OT) 37 (3.2%) 42 (3.6%) -0.4% (-1.9%; +1.1%)  *estimated cumulative risk; **rounded figures; CI = confidence interval; ITT = intention-to-treat; OT = on-treatment
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