Home  Media Press releases 2003
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| 23 December 2003 | 2003-12-23T00:00:00.0000000-00:00 |
| EXANTA™ (XIMELAGATRAN) REGULATORY FILINGS SUBMITTED IN UNITED STATES (US) AND EUROPEAN UNION (EU) FOR KEY CHRONIC INDICATIONS
AstraZeneca has submitted Exanta™ the first oral direct thrombin inhibitor, for regulatory review in the EU and US in key chronic-use indications. In the US, submissions have been made to the Food and Drug Administration (FDA) for Exanta in the prevention of stroke and other thromboembolic complications associated with atrial fibrillation (AF) and long-term secondary prevention of venous thromboembolism (VTE), after standard treatment for an episode of acute VTE. In Europe, regulatory submissions have been made to the Reference Member State, France, as part of the Mutual Recognition Procedure for use of Exanta in prevention of stroke and other thromboembolic complications associated with AF and the treatment of VTE. | Exanta is the first oral treatment in a new World Health Organisation class of direct thrombin inhibitors (DTIs) and is the first new oral anticoagulant to reach regulatory review since the introduction of warfarin almost 60 years ago. These submissions collectively comprise one of the largest-ever regulatory filings and are based on an extensive clinical study programme involving around 30,000 patients.
Exanta has the potential to meet an important unmet medical need in these long-term chronic indications involving prevention or treatment of venous thromboembolic events. For example, in the prevention of stroke in patients with AF, studies have shown that the risk of stroke can be reduced by 62 per cent in patients taking oral anticoagulant therapy, and that around 50 per cent of eligible patients do not currently receive optimal treatment. Exanta benefits from administration as a fixed oral dose, has a rapid onset and offset of action and shows low potential for food and drug interactions. Importantly, coagulation monitoring and dose titration are also not necessary in treatment with Exanta.
“We are very proud to have reached this important milestone in the development of Exanta as an innovative new oral anticoagulant,” commented Dr Hamish Cameron, Vice President, Head of Exanta, AstraZeneca. “We will now work closely with regulatory authorities throughout the review process as the next step towards introducing this innovative new treatment to medical practice.”
Although existing anticoagulant treatments are effective, they are also associated with many limitations. While some require subcutaneous or intravenous administration, the current standard oral treatment, warfarin, is limited by extensive drug and food interactions and the need for routine coagulation monitoring and dose titration.
A submission for prevention of venous thromboembolic events in major elective orthopaedic (knee replacement) surgery has also been submitted in the US to the FDA this month.
For further information, please see www.astrazenecapressoffice.com or contact:
Media Enquiries:
Chris Major, +44 (0) 207 304 5028
Investor Enquiries:
Mina Blair-Robinson, +44 (0) 207 304 5084
Jonathan Hunt, +44 (0) 207 304 5087
Notes to Editors
· Exanta is a trademark of the AstraZeneca group of companies.
· 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 top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.
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