文档介绍：Tysabri® (natalizumab) Biogen Idec Inc. BLA 125104/15
Peripheral and Central Nervous System
Drugs mittee
Gaithersburg, Maryland
March 7-8, 2006
Alice Hughes, .
Division of Neurology Products
Center for Drug Evaluation and Research
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1
Review of Non-PML Safety Issues
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2
Outline
Infections other than PML
Immunogenicity and hypersensitivity reactions
Carcinogenicity
Post-marketing reports of serious adverse events
Summary of major safety concerns
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3
Natalizumab- and placebo-treated patients had similar incidences of:
infections overall: % vs. % (natalizumab vs. placebo)
serious infections: % vs. %
Natalizumab- and placebo-treated patients had similar incidences of:
upper respiratory tract infections: % vs. %
UTIs: % vs. %
serious UTIs: % vs. %
gastroenteritis: % vs. %
Infections other than PML: Placebo-controlled MS studies
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4
Infections other than PML: MS studies
Incidences of specific infections in placebo-controlled studies:
all lower respiratory tract infections: % vs. % (natalizumab vs. placebo)
serious pneumonias: % vs. %
vaginal infections: % vs. %
all herpes infections: % vs. %
gingival infections: % vs. %
Atypical infections
cryptosporidial gastroenteritis with prolonged course (in monotherapy Study 1801)
acute CMV infection with transaminitis (in open-label Study 1808)
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5
Infections other than PML: Placebo-controlled CD studies
Incidence of infections overall:
% vs. % (natalizumab vs. placebo)
Incidence of serious infections:
% vs. %
Incidences of selected infections:
URIs: 27% vs. 21