Exanta

ximelagatran

FDA Advisory Committee Recommends Further Data to Support Approval of AstraZeneca's Oral Anticoagulant Exanta

WILMINGTON, Del., September 10, 2004 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE:AZN) 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 Exanta (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 program 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.

About AstraZeneca
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 cardiovascular, gastrointestinal, oncology, neuroscience and respiratory products. In the United States, AstraZeneca is an $8.7 billion healthcare business with more than 11,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

For more information about AstraZeneca, please visit www.astrazeneca-us.com.

Related Articles:

AstraZeneca Receives Action Letter From FDA for Exanta (ximelagatran) - October 8, 2004

Latest New Drug Applications...

Pharma News
New Drug Applications
New Drug Approvals
Clinical Trial Results
Generic Drug Approvals