AstraZeneca PLC
13 September 2004
FDA ADVISORY COMMITTEE RECOMMENDS FURTHER DATA TO SUPPORT APPROVAL OF
ASTRAZENECA'S
ORAL ANTICOAGULANT EXANTATM (XIMELAGATRAN)
AstraZeneca today announced that the Cardiovascular and Renal Drugs Advisory
Committee to the US FDA has advised that more data is needed to support the
approval of the oral anticoagulant ExantaTM (ximelagatran).
Despite the Committee members' recognition of the need for a new oral therapy to
complement warfarin in the treatment of thrombotic disorders, the Committee
advised that the indications for the prevention of strokes in patients with
atrial fibrillation (AF), for the prevention of blood clots in patients
undergoing knee replacement surgery, and for the long term secondary prevention
of blood clots following standard treatment of a clot, should not be recommended
on present data.
Sir Tom McKillop, Chief Executive of AstraZeneca, said 'We are disappointed with
the outcome of the Advisory Committee, particularly for patients who need an
effective alternative therapy to warfarin, the only existing oral anticoagulant.
We will now continue our discussions with the FDA on a way forward for Exanta.'
Exanta is an investigational oral direct thrombin inhibitor (oral DTI) and is
poised to be the first oral anticoagulant since the development of warfarin more
than 50 years ago. More than 30,000 patients in over 25 countries have
participated in the clinical trial programme for Exanta to date, with more than
17,000 patients receiving Exanta. Exanta was studied as a fixed, oral dose with
no titration or coagulation monitoring.
13 September 2004
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