After reviewing the Exanta (ximelagatran) regulatory submission made in December 2003, the French Regulatory Authority (AFSSAPS) told AstraZeneca that it will require more information before the drug can be considered for approval for long-term use in Europe.
The French authority has been reviewing data on Exanta in the prevention of stroke and other thromboembolic complications associated with atrial fibrillation (AF) and the treatment of venous thromboembolism (VTE).
AFSSAPS has requested further clinical information confirming the efficacy and safety of Exanta in AF to allow a definitive benefit/ risk assessment to be made while, for VTE treatment, the authority does not believe the data presented in the single THRIVE study provides adequate support for this use of Exanta and is proposing a rejection of this indication.
AstraZeneca will now enter into discussions with AFSSAPS to examine what additional data needs to be generated for the AF file to be progressed further.
In May 2004, Exanta was approved by the European regulatory authorities for a short-term indication in the prevention of blood clots in patients undergoing hip- or knee-replacement surgery.