FOOD AND
DRUG ADMINISTRATION
Center for Drug Evaluation and Research
Arthritis Advisory Committee
Slides
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
Sponsor Presentation
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
FDA Presentation
BLA 125118, Abatacept Keith
Hull, M.D., Medical Officer
[HTML] [PPT] Division
of Therapeutic Biological Internal
Medicine
Products, FDA
Questions to the
Committee