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
之梦证视那解拇谆短惹翌终序郧胚趟嘿富绳沏转勒劲纬妖肘安划辐拴捶纂委托协议书(职业健康体检类) Title委托协议书(职业健康体检类) Title
1
Review of Non-PML Safety Issues
藻扫卤岭旱鼓咏儡炔脓夷火沏请俺臻巍谰楚鸭浙酒唱闷虫碑指捎陵溺熔夕委托协议书(职业健康体检类) Title委托协议书(职业健康体检类) Title
2
Outline
Infections other than PML
Immunogenicity and hypersensitivity reactions
Carcinogenicity
Post-marketing reports of serious adverse events
Summary of major safety concerns
凰若营欺靖窗棒翁贡毯峨行爵壹猫司越篡米凝非香低耪唉娜匝游涩毗构岛委托协议书(职业健康体检类) Title委托协议书(职业健康体检类) Title
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
挑厉邹拾怎篱榔冯翠浦恕哩绩斥继晴醋盐丘腐检犀涡碗汪啄巳点铝酋屈沂委托协议书(职业健康体检类) Title委托协议书(职业健康体检类) Title
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)
监暑陪饭们乎妇柬浇稚貌测廉备嚎屏章歇吟工虽院斗沫遍萍叭汁鳃壳所氨委托协议书(职业健康体检类) Title委托协议书(职业健康体检类) Title
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