Food and Drug Administration
Center for Drug Evaluation and Research
Dermatologic and Ophthalmic Drugs Advisory Committee
BLA - STN # 125075/0, Efalizumab, (Raptiva) by Genentech, Inc. to be used in the treatment of adult patients with moderate to severe plaque psoriasis
Call to Order and Opening Remarks Robert S. Stern, M.D.
Conflict of Interest Statement Kimberly L. Topper, M.S.
Introduction to Efalizumab Steven Kozlowski, M.D.
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.
Review of Efficacy and Safety Results Elektra Papadopoulos, M.D.
Open Public Hearing