Cardiovascular and Renal Drugs Advisory Committee Meeting

September 10, 2004


Holiday Inn, Versailles Ballrooms, Bethesda, MD






8:30a.m. Call to Order and Introductions Jeffery Borer, M.D.

Acting Chair

Cardiovascular and Renal Drugs

Advisory Committee

Conflict of Interest Statement LCDR Dornette Spell-LeSane, NP-C

Executive Secretary

Cardio-Renal Advisory Committee


8:45a.m. Welcome and Comments Norman Stockbridge, M.D.

Acting Director,

Division of Cardiovascular and

Renal Drugs, FDA



The Committee will discuss new drug application (NDA) 21-686 proposed trade name Exanta (ximelagatran) tablets, AstraZeneca, for the proposed indication of the prevention of venous thromboembolism (VTE) in patients undergoing knee replacement surgery, the prevention of stroke and other thromboembolic complications associated with atrial fibrillation and the long term secondary prevention of VTE after standard treatment of an episode of acute VTE.



9:00 a.m. Sponsor Presentation


Introduction Hamish Cameron, M.D.

Vice President, Exanta



Clinical Pharmacology Troy C. Sarich, Ph.D.

Director, Clinical Pharmacology



Safety Sunita Sheth, M.D., FAHA

Senior Director, Clinical Development


Efficacy Jay Horrow, M.D., MS

Senior Director, Clinical Development

Sponsor Presentation Cont.



Benefit and Risk Anticoagulation Jonathan L. Halperin, M.D.

Mount Sinai Medical Center

New York, New York


10:30 10:45 Questions from the Committee


10:4511:00 Break



11:00 FDA Presentation

Risk Benefit Assessment Ruyi He, M.D., Medical Officer

Division of Gastrointestinal and

Coagulation Drug Products


Drug Induced Liver Toxicity TBA



Risk Management of Hepatotoxic Kate Gelprin, M.D., M.P.H.,

Drugs Medical Epidemiologist

Division of Drug Risk Evaluation



11:55 12:15 Questions from the Committee


12:15 1:00 Lunch


1:00 2:00 Open Public Hearing



2:00 2:15 Charge to the Committee Joyce Korvick, M.D., M.P.H.

Acting Division Director

Division of Gastrointestinal and Coagulation Drug Products, FDA


2:15 3:00 Committee Discussions


3:00 3:15 Break


3:15 4:50 Committee Questions/Summary


5:00 p.m. Adjournment