Exanta NDA dropped due to liver injury
This article was originally published in Pharmaceutical Approvals Monthly
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...
FDA co-hosts a two-day conference to address questions raised by pharmaceutical company comments on the agency's draft guidance on studying drug-induced liver injury.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
AstraZeneca will submit additional data for Symbicort inhalation delivery device. Hold-up comes in wake of setbacks for Iressa, Exanta and Crestor
A new analysis of the ADAURA study shows that Tagrisso’s disease-free survival benefits in early stage EGFRm NSCLC are replicated for brain metastases, a common complication with a poor prognosis. Filings and OS data await.