委托协议书(职业健康体检类) Title.ppt

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1、Tysabri®(natalizumab)BiogenIdecInc.BLA125104/15PeripheralandCentralNervousSystemDrugsAdvisoryCommitteeGaithersburg,MarylandMarch7-8,2006AliceHughes,M.D.DivisionofNeurologyProductsCenterforDrugEvaluationandResearch1ReviewofNon-PMLSafetyIssues2OutlineInfectionsotherthanPMLI

2、mmunogenicityandhypersensitivityreactionsCarcinogenicityPost-marketingreportsofseriousadverseeventsSummaryofmajorsafetyconcerns3Natalizumab-andplacebo-treatedpatientshadsimilarincidencesof:infectionsoverall:73.7%vs.73.9%(natalizumabvs.placebo)seriousinfections:2.4%vs.2.3%Na

3、talizumab-andplacebo-treatedpatientshadsimilarincidencesof: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-controlledMSstudies4InfectionsotherthanPML:MSstudiesIncidencesofspeci

4、ficinfectionsinplacebo-controlledstudies:alllowerrespiratorytractinfections: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%Atypicalinfectionscryptosporidialgastroente

5、ritiswithprolongedcourse(inmonotherapyStudy1801)acuteCMVinfectionwithtransaminitis(inopen-labelStudy1808)5InfectionsotherthanPML:Placebo-controlledCDstudiesIncidenceofinfectionsoverall:40.4%vs.35.8%(natalizumabvs.placebo)Incidenceofseriousinfections:2.5%vs.2.6%Incidencesof

6、selectedinfections:URIs:27%vs.21%UTIs:2.9%vs.2.0%vaginalinfections:2.1%vs.1.6%allherpesinfections:1.6%vs.1.0%perianalabcesses:1.1%vs.0.6%seriousviralmeningitides:0.2%(2)vs.0seriousUTIs:0.2%(2)vs.0OneseriousCMVinfection(CMVcolitis)Patientalsoreceivingazathioprine6Infectionso

7、therthanPML:Long-termCDstudiesAtypicalInfectionsSixseriousatypicallowerrespiratorytractinfectionsPneumoniawithlungabscessPulmonaryaspergillosisPneumocystiscariniipneumoniaVaricellapneumoniaMycobacteriumaviumintracellularecomplexpneumoniaBurkholderiacepaciainfectionPossible

8、tuberculosisinfectionUnclearroleofconcomitantimmunosuppressive/immunomodulatoryage