Center for Drug Evaluation and Research

Arthritis Advisory Committee






September 6, 2005:


The committee will discuss Biologics Application (BLA) 125118 Abatacept, Bristol Myers Squibb, proposed trade

name Orencia, proposed indication for the treatment of moderately to severely active Rheumatoid Arthritis.


             Abatacept (CTLA4-Ig) for the Treatment                           Joy Williams, Ph.D.

of Rheumatoid Arthritis: Product Attributes                      Division of Therapeutic Proteins, FDA

and Mechanism of Action

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             Sponsor Presentation                                                  Bristol Myers Squibb

            Introductory Remarks                                                     Brian Daniels, M.D.

                                                                                                Senior Vice President, Global Clinical Development      

            Introduction to the Product &                                          Anthony Waclawski, Ph,D,

            Session Moderator                                                        Executive Director, Global Regulatory Science  


            Efficacy Presentation                                                     George Vratsanos, M.D.

                                                                                                Director, Clinical Research


            Safety Presentation                                                       Daniel MacNeil, M.D.

                                                                                                Executive Director, Clinical Safety


            Closing Comments                                                        Brian Daniels, M.D.

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            Sponsor Backup Slides

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             FDA Presentation


            BLA 125118, Abatacept                                                 Keith Hull, M.D., Medical Officer

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                                                                                    Medicine Products, FDA           


            Questions to the Committee

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