Center for Drug Evaluation and Research (CDER)
Arthritis Advisory Committee (AAC)
8:30 a.m. Call to Order Dennis Turk, Ph.D.
Introduction of Committee Acting Chair, AAC
Conflict of Interest Statement Johanna Clifford, M.Sc., RN
Designated Federal Official, AAC
Division of Anesthesia, Analgesia & Rheumatology Products (DAARP), CDER, FDA
The committee will discuss new drug application (NDA) 21-389/21-772, ARCOXIA (etoricoxib), Merck & Co., Inc., proposed treatment for the relief of signs and symptoms of osteoarthritis.
9:00 a.m. History of Cardiovascular Findings Sharon Hertz, M.D., Deputy Director
from NSAID Studies DAARP, CDER, FDA
9:20 a.m. Sponsor
Introduction Scott Korn, M.D.
Executive Director, Regulatory Affairs
Merck Research Labs (MRL)
Unmet Medical Need in OA Grant Cannon, M.D.
Professor of Medicine
Efficacy & Safety Summary Sean Curtis, M.D.
Executive Director, Clinical Research, MRL
10:35 a.m. FDA Presentation
Medical Review Robert Shibuya, M.D., Medical Officer
Etoricoxib Application DAARP, CDER, FDA
An Epidemiologic Perspective David Graham, M.D., MPH
11:35 a.m. Break
11:45 p.m. Open Public Hearing
12:45 p.m. Lunch
1:30 p.m. Questions from the Committee
2:30 p.m. Break
2:45 p.m. Questions to the AAC and AAC Discussion
5:00 p.m. Adjourn