Food and Drug Administration
Center for Drug Evaluation and Research
Arthritis Advisory Committee
CDER Advisory Committee Conference Room
5630 Fishers Lane, Room 1066, Rockville, MD
April 19, 2001
NDA # 21-239 ASLERA™ (prasterone, Genelabs Technologies, Inc.)
8:00 Call to Order and Introductions: E. Nigel Harris, M.D., Acting Chair
Meeting Statement: Kathleen Reedy, Executive Secretary
8:15 Welcome and Introduction: Jonca C. Bull, M.D., Acting Director
Division of Anti-Inflammatory, Analgesic, and Ophthalmic Drug Products
Regulatory Background: Kent R. Johnson, M.D., Medical Officer, DAAODP
8:30 Genelabs Technologies Inc. Presentation
Overview: Marc Gurwith, MD, JD, Vice President, Drug Development,
Chief Medical Officer, Genelabs Technologies, Inc.
Introduction: Robert Lahita, MD, PhD, Professor of Medicine,
Saint Vincentís Medical Center
Summary of Efficacy: Michelle Petri, MD, MPH, Associate Professor of Medicine
Johns Hopkins Medical Center
Clinical Perspective: Murray Urowitz, MD, FRCPC, Professor of Medicine
University of Toronto
10:15 FDA Presentation
Pharmacology/Toxicology: Susan Wilson, D.V.M. , Ph.D.
Clinical Pharmacology: Abimbola Adebowale, Ph.D.
Medical: Kent R. Johnson, M.D.
Statistical: Laura Lu, Ph.D.
11:15 Open Public Hearing
1:00 Discussion and Questions:
3:30 Summary and Review