July 16, 2003 Results presented at the XIXth Congress of the International Society on Thrombosis and Haemostasis, ongoing in the U.K., provide a limited update of previous THRIVE data. These results support the hypothesis that AstraZeneca’s (NYSE: AZN) Exanta (ximelagatran) is not inferior to enoxaparin/warfarin for the prevention of recurrent venous thromboembolism (VTE) in patients with acute deep vein thrombosis (DVT) with or without pulmonary embolism (PE). Although efficacy parameters remained the same, the focus of the update centered upon Exanta’s less favorable propensity to elevate liver enzymes levels (9.6% versus 2%).
These potential markers of liver dysfunction are likely to be of limited clinical consequence for most affected recipients, and are not likely to influence regulatory approval of the drug given that the liver enzyme elevations were “typically transient and not associated with any specific clinical symptoms.” Nevertheless, the likely requisite for frequent blood draws to obtain liver function tests threatens a major convenience advantage Exanta otherwise would have held. Unlike warfarin-based anticoagulant formulations such as Bristol Myers Squibb’s (NYSE: BMY) Coumadin, Exanta recipients do not require frequent blood draws in order to monitor their risk for over-anticoagulation that would lead to bleeding or under-anticoagulation that would lead to clotting.
The degree to which these findings are likely to influence Exanta sales potential will become more clear during presentations and discussions with clinicians, including those at the American Society of Hematology’s 45th Annual Meeting and Exposition, December 6-9, 2003, in San Diego.
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