委托协议书(职业健康体检类) TITLE精选.pptVIP

Tysabri? (natalizumab)Biogen Idec Inc.BLA 125104/15 Peripheral and Central Nervous System Drugs Advisory Committee Gaithersburg, Maryland March 7-8, 2006 Alice Hughes, M.D. Division of Neurology Products Review of Non-PML Safety Issues Outline Infections other than PML Immunogenicity and hypersensitivity reactions Carcinogenicity Post-marketing reports of serious adverse events Summary of major safety concerns Infections other than PML:Placebo-controlled MS studies Natalizumab- and placebo-treated patients had similar incidences of: infections overall: 73.7% vs. 73.9% (nata