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

 

10:45 − 11:00                                                                             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