AstraZeneca PLC
19 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 announced
receipt of 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 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 and is proposing a rejection of this indication.
AstraZeneca will now have discussions with AFSSAPS to examine what additional
data needs to be generated for the AF file to be progressed further.
Given the limitations of current therapy in the prevention of thrombosis in
patients with atrial fibrillation and its potentially life threatening
complications, this remains an area of great unmet need. AstraZeneca remains
committed to research in this area of medicine.
In May 2004, Exanta was approved by the European regulatory authorities for the
short-term indication: 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. Through the EU MRP process, Exanta received approval for this
indication in 15 European countries and approval was also granted in Switzerland
and 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 indication
in: 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-
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