Food and Drug Administration

Center for Drug Evaluation and Research

Arthritis Advisory Committee

Silver Spring Holiday Inn, 8777 Georgia Avenue, Silver Spring, MD



March 5, 2003

NDA: 20-905, ARAVA, (leflunomide), Aventis Pharmaceuticals Inc.


8:00 Call to Order and Introductions: Steven B. Abramson,, M.D., Acting Chair

Meeting Statement: Kathleen Reedy, Executive Secretary

Welcome: Lee S. Simon, M.D., Director, Division of AntiInflammatory, Analgesic

and Ophthalmalogic Drug Products

8:15 Open Public Hearing


9:00 Regulatory History: Arava and Treatment of Rheumatoid Arthritis:

Lee S. Simon, M.D.


9:25 Health Assessment Questionnaire: James F. Fries, M.D., Stanford University


9:50 Break


10:10 Aventis Presentation: Efficacy: Michael Rozycki, Ph.D.

Joseph Doyle, R.PH., MBA.

Karen Simpson, M.D.


10:55 Statistics: Suktae Choi, Ph.D., FDA


11:05 Discussion and Questions: Efficacy

12:00 Lunch


1:00 Open Public Hearing (if needed)


1:00 FDA Presentation: Safety: Lawrence Goldkind, M.D., FDA


2:00 Aventis Presentation: Safety: Michael Rozycki, Ph.D.

William Holden, M.D.

Vibeke Strand, M.D.


2:45 Break


3:00 Discussion of labeling rare serious events: Ruth Day, Ph.D., Duke University

3:30 Discussion and Questions: Safety


5:00 Adjourn