Food and Drug Administration
Center for Drug Evaluation
and Research
Arthritis Advisory Committee
Silver Spring Holiday Inn, 8777 Georgia Avenue, Silver
Spring, MD
Agenda
March 5, 2003
NDA:
20-905, ARAVAÔ, (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