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)...