FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
Arthritis Advisory Committee
The committee will discuss Biologics
Application (BLA) 125118 Abatacept,
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
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.
Sponsor Backup Slides
BLA 125118, Abatacept Keith Hull, M.D., Medical Officer
Medicine Products, FDA
Questions to the Committee