Home  Media Press releases 2005
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| 19 January 2005 | 2005-01-19T00:00:00.0000000-00:00 |
| FURTHER CLINICAL INFORMATION REQUESTED ON EXANTA® (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® regulatory submission made in December 2003 AstraZeneca 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,” commented Dr Hamish Cameron, Vice President, Head of Exanta, AstraZeneca. “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. Exanta has since been made available in nine European countries and Argentina.
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
Notes to Editors:
· Exanta is a trademark of the AstraZeneca group of companies.
· Exanta has through the EU MRP process received approval in 15 European countries for the short-term indication, the prevention of blood clots in patients undergoing hip- or knee-replacement surgery, and approval in this indication has also been 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 indication in: Germany, Portugal, Sweden, Finland, Norway, Iceland, Austria, Denmark, Switzerland and Argentina.
· AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
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