AstraZeneca 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 Exanta (ximelagatran).
According to a company release, 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, the release says.