FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

 

Cardiovascular and Renal Drugs Advisory Committee Meeting

September 10, 2004

 

Holiday Inn, Versailles Ballrooms, Bethesda, MD

 

DRAFT AGENDA

 

 

 

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