19th Jan 2005 14:30
AstraZeneca PLC19 January 2005 FURTHER CLINICAL INFORMATION REQUESTED ON EXANTA(R) (XIMELAGATRAN) FOR THE PREVENTION OF STROKE IN PATIENTS WITH ATRIAL FIBRILLATION IN EUROPE Following the review by the French Regulatory Authority (AFSSAPS) of the Exanta(R) regulatory submission made in December 2003 AstraZeneca has today announcedreceipt of a request for more information before the drug can be considered forapproval of long-term use in Europe. The French authority has been acting as the Reference Member State for theEuropean Mutual Recognition Procedure (MRP) and has been reviewing data onExanta in the prevention of stroke and other thromboembolic complicationsassociated with atrial fibrillation (AF, an irregular heartbeat) and thetreatment of venous thromboembolism (VTE). AFSSAPS has requested further clinical information confirming the efficacy anddemonstrating safety of Exanta in AF to allow a definitive benefit/ riskassessment to be made while, for VTE treatment, the authority does not believethe data presented in the single THRIVE Treatment study provides adequatesupport for this use of Exanta and is proposing a rejection of this indication.AstraZeneca will now have discussions with AFSSAPS to examine what additionaldata needs to be generated for the AF file to be progressed further. Given the limitations of current therapy in the prevention of thrombosis inpatients with atrial fibrillation and its potentially life threateningcomplications, this remains an area of great unmet need. AstraZeneca remainscommitted to research in this area of medicine. In May 2004, Exanta was approved by the European regulatory authorities for theshort-term indication: the prevention of blood clots in patients undergoing hip-or knee-replacement surgery. This included a commitment to perform anadditional study post-approval and the protocol is currently under discussionwithin the EU. Through the EU MRP process, Exanta received approval for thisindication in 15 European countries and approval was also granted in Switzerlandand Argentina. MRP countries include: Austria, Belgium, Denmark, Finland,France, Germany, Greece, Italy, Luxembourg, the Netherlands, Portugal, Spain,Sweden, Iceland and Norway. Exanta is launched in this short- term indicationin: Germany, Portugal, Sweden, Finland, Norway, Iceland, Austria, Denmark,Switzerland and Argentina. 19 January 2005 Media Enquiries: Edel McCaffrey, Tel: +44 (0) 207 304 5034 Steve Brown, Tel: +44 (0) 207 304 5033 Investor Enquiries: Mina Blair, Tel: +44 (0) 207 304 5084 Jonathan Hunt, Tel: +44 (0) 207 304 5087 -ends- This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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