Further clinical information requested on Exanta
Following the review by the French Regulatory Authority (AFSSAPS) of the Exanta regulatory submission made in December 2003, AstraZeneca has received a request for more information before the drug can be considered for approval of long-term use in Europe.
Following the review by the French Regulatory Authority (AFSSAPS) of the Exanta regulatory submission made in December 2003, AstraZeneca has received a request for more information before the drug can be considered for approval of long-term use in Europe.
The French authority has been acting as the reference member state for the European Mutual Recognition Procedure (MRP) and has been reviewing data on Exanta in the prevention of stroke and other thromboembolic complications associated with atrial fibrillation (AF, an irregular heartbeat) and the treatment of venous thromboembolism (VTE).
AFSSAPS has requested further clinical information confirming the efficacy and demonstrating the 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 Treatment study provides adequate support for this use of Exanta. AstraZeneca will now have 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 short-term indication in the prevention of blood clots in patients undergoing hip- or knee-replacement surgery. This included a commitment to perform an additional study post-approval and the protocol is currently under discussion within the EU. Exanta has since been made available in nine European countries and Argentina.