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)...
You may also be interested in...
Drug-Induced Liver Injury Workshop Offers More Questions Than Answers
FDA co-hosts a two-day conference to address questions raised by pharmaceutical company comments on the agency's draft guidance on studying drug-induced liver injury. While FDA, industry and academics agreed that patients with underlying liver disease should be included in trials in order to better test a real-world population, there is no consensus on how to do so safely
Symbicort NDA On-Track, Exanta Decision Set For Second-Half – AstraZeneca
AstraZeneca will submit additional data for Symbicort inhalation delivery device. Hold-up comes in wake of setbacks for Iressa, Exanta and Crestor
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”