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Food and Drug Administration

Arthritis Advisory Committee

April 12, 2007

The committee discussed new drug application (NDA) 21-389/21-772, ARCOXIA (etoricoxib), Merck & Co., Inc., proposed treatment for the relief of signs and symptoms of osteoarthritis.


FDA Presentation

History of Cardiovascular Findings from NSAID studies, Sharon Hertz, M.D., Deputy Director DAARP, CDER, FDA (PPT) (HTM)

Medical Review: Etoricoxib Application, Robert Shibuya, M.D., Medical Officer, DAARP, CDER, FDA (PPT) (HTM)

An Epidemiologic Perspective on Etoricoxib, Office of Surveillance and Epidemiology, David J. Graham, M.D., CDER, FDA (PPT) (HTM)

Sponsor Presentation

Osteoarthritis: Disease Burden and Unmet Patient Needs, Grant W. Cannon, M.D. Division of Rheumatology, University of Utah (PDF)

Efficacy and Safety Summary, Sean Curtis, M.D. Executive Director, Clinical Research, Merck Research Laboratories (MRL), core and backup slides (PDF)

Open Public Hearing Speakers

 David Egilman, M.D., MPH, Clinical Associate Professor, Brown University (PPT) (HTM)

 Sid Wolfe, M.D., Director Public Citizen Health Research Group (PPT) (HTM)


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