Food and Drug Administration

Center for Drug Evaluation and Research

Dermatologic and Ophthalmic Drugs Advisory Committee

Holiday Inn, Montgomery Village Avenue, Gaithersburg, Maryland

September 9, 2003

Draft Agenda

BLA - STN # 125075/0, Efalizumab, (Raptiva) by Genentech, Inc. to be used in the treatment of adult patients with moderate to severe plaque psoriasis


8:30 Call to Order and Opening Remarks Robert S. Stern, M.D.

Conflict of Interest Statement Kimberly L. Topper, M.S.

8:50 Introduction to Efalizumab Steven Kozlowski, M.D.

9:00 Genentech Presentation

Introduction Michelle Rohrer, Ph.D.


Moderate to Severe Psoriasis The Unmet Need Mark G. Lebwohl, M.D.


Mechanism of Action and Dose Determination Charles Johnson, M.B., Ch.B.

Efficacy Lee Kaiser, Ph.D.

Safety Richard Chin, M.D.

Raptiva Benefit: Risk Profile Charles Johnson, M.B., Ch.B.

10:00 Committee Discussion


10:30 Break


10:45 FDA Presentation

Review of Efficacy and Safety Results Elektra Papadopoulos, M.D.


11:45 Committee Discussion


12:15 Lunch


1:15 Open Public Hearing


2:15 Committee Discussion


3:15 Break


3:30 Questions


5:30 Adjourn