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