委托协议书(职业健康体检类) title课件

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1、Tysabri®(natalizumab)BiogenIdecInc.BLA125104/15PeripheralandCentralNervousSystemDrugsAdvisoryCommitteeGaithersburg,MarylandMarch7-8,2006AliceHughes,M.D.DivisionofNeurologyProductsCenterforDrugEvaluationandResearch2ReviewofNon-PMLSafetyIssues3OutlineInfectionsotherthanPMLImmunogenicityandh

2、ypersensitivityreactionsCarcinogenicityPost-marketingreportsofseriousadverseeventsSummaryofmajorsafetyconcerns4Natalizumab-andplacebo-treatedpatientshadsimilarincidencesof:infectionsoverall:73.7%vs.73.9%(natalizumabvs.placebo)seriousinfections:2.4%vs.2.3%Natalizumab-andplacebo-treatedpatien

3、tshadsimilarincidencesof:upperrespiratorytractinfections:59.6%vs.59.8%UTIs:21.5%vs.21.4%seriousUTIs:0.6%vs.0.5%gastroenteritis:9.1%vs.9.0%InfectionsotherthanPML:Placebo-controlledMSstudies5InfectionsotherthanPML:MSstudiesIncidencesofspecificinfectionsinplacebo-controlledstudies:alllowerre

4、spiratorytractinfections:13.3%vs.12.2%(natalizumabvs.placebo)seriouspneumonias:0.4%vs.0.2%vaginalinfections:7.5%vs.6.2%allherpesinfections:7.0%vs.6.1%gingivalinfections:1.1%vs.0.5%Atypicalinfectionscryptosporidialgastroenteritiswithprolongedcourse(inmonotherapyStudy1801)acuteCMVinfectionwit

5、htransaminitis(inopen-labelStudy1808)6InfectionsotherthanPML:Placebo-controlledCDstudiesIncidenceofinfectionsoverall:40.4%vs.35.8%(natalizumabvs.placebo)Incidenceofseriousinfections:2.5%vs.2.6%Incidencesofselectedinfections:URIs:27%vs.21%UTIs:2.9%vs.2.0%vaginalinfections:2.1%vs.1.6%allherp

6、esinfections:1.6%vs.1.0%perianalabcesses:1.1%vs.0.6%seriousviralmeningitides:0.2%(2)vs.0seriousUTIs:0.2%(2)vs.0OneseriousCMVinfection(CMVcolitis)Patientalsoreceivingazathioprine7InfectionsotherthanPML:Long-termCDstudiesAtypicalInfectionsSixseriousatypicallowerrespiratorytractinfectionsPneu

7、moniawithlungabscessPulmonaryaspergillosisPneumocystiscariniipneumoniaVaricellapneumoniaMycobacteriumaviumintracellularecomplexpneumoniaBurkholderiacepaciainfectionPossibletuberculosisinfectionUnclearroleofconcomitantimmunosuppressive/immunomodulatoryage