Center for Drug Evaluation and Research (CDER)

Arthritis Advisory Committee (AAC)



April 12, 2007


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


8:45 a.m.         Opening Remarks                                Bob Rappaport, M.D., Director

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 Presentation                         Merck Co., Inc.


                        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

                                                                                    University of Utah, Division of Rheumatology


                        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

            on Etoricoxib                                       Office of Surveillance and Epidemiology, CDER, FDA


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