Center
for Drug Evaluation and Research (CDER)
Peripheral and Central Nervous System
Drugs Advisory Committee
March
7 and 8, 2006
Holiday
Inn
-- Slides presented at Hearing --
The committee will discuss Tysabri (Natalizumab)
biologic license application 125104/15; Biogen Idec Inc. for an indication in
patients with relapsing forms of multiple sclerosis to reduce the frequency of
clinical exacerbations. The committee will discuss the risks (including progressive multifocal leukoencephalopathy
(PML)) associated with Tysabri administration, the efficacy of Tysabri in the
treatment of multiple sclerosis relapses and/or disability, the possible return
of Tysabri to the marketplace, and proposed risk management plan(s) for
Tysabri.
____________________________________________________________________________________________________________________________________________
Call to Order and Introductions Karl
Kieburtz, M.D., M.P.H.
Chair, Peripheral and Central Nervous System Drugs
Advisory Committee (PCNS)
Conflict of Interest Statement
Acting Executive Secretary, PCNS
Opening Remarks and Overview of
Issues Russell Katz,
M.D.
Director, Division of Neurology Products (DNP), FDA
Sponsor Presentations Biogen Idec Inc.
PPT Introduction Burt
Adelman, M.D.
Executive Vice President, Development
Biogen Idec Inc.
PPT Efficacy Data Alfred
Sandrock, M.D., Ph.D.
Vice President, Neurology
Biogen Idec Inc.
PPT Safety
Data Michael
Panzara, M.D., M.P.H
Vice President,
Neurology
Biogen Idec Inc.
PPT Risk-Management Plan Carmen
Bozic, M.D.
Vice President, Drug Safety and Risk Management
Biogen Idec Inc.
PPT Clinical Perspective Richard
A. Rudick, M.D.
Director,
The
Chairman, Division of Clinical Research
FDA Presentation
FDA
PPT Background, Efficacy and PML Susan McDermott,
M.D.
Clinical Reviewer, DNP, FDA
PPT Safety Alice
Hughes, M.D.
Clinical Safety Reviewer, DNP, FDA
PPT Risk Minimization Action Plan Diane
Wysowski, Ph.D.
Reviewer, Office of Drug Safety, FDA
Open Public
Hearing
PPT Alex
MacDonald
PDF Lauren Roberts (Written Statement Submitted with Video, Video
Testimony Available at Dockets Per Request)
Karen Fuquay (Video Testimony
available at Dockets Per Request)
PPT Frank
Burroughs (Abigail
March 8, 2006
Call to Order and Introductions Karl
Kieburtz, M.D., M.P.H.
Chair, Peripheral and Central Nervous System Drugs
Advisory Committee (PCNS)
Conflict of Interest Statement
Acting Executive Secretary, PCNS
PPT Opening Remarks and Overview of Issues Russell Katz, M.D.
Director, Division of Neurology Products (DNP), FDA
PPT Questions