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Exanta NDA dropped due to liver injury

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

AstraZeneca withdraws pending NDA for anticoagulant Exanta (ximelagatran) following a report of serious liver injury, the firm announces Feb. 14. The company also is discontinuing two ongoing trials and will switch Exanta-treated patients to other therapies. The decision was triggered by new findings in the EXTEND trial for prevention of venous thromboembolism following orthopedic surgery. Exanta had received a "not approvable" letter in October 2004 in the wake of an advisory committee recommendation against approval due to liver toxicity concerns. The firm has a backup compound - AZD 0837 - in Phase II studies (1Pharmaceutical Approvals Monthly February 2005, p. 20)...

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