AcceptanceisbasedonpivotalPhase3datademonstratingrapid,durableandconsistentskinclearance,includinginhigh-impactsites,inaconvenientonce-dailypill
    Resultsfromnearly3,000patientssupportpotentialfornext-generationTYK2inhibitortoredefineoraltreatmentexpectationsinpsoriasis
    ThePrescriptionDrugUserFeeAct(PDUFA)targetactiondateisinthefirstquarterofcalendaryear2027
    OrderDNAKits
    OSAKA,Japan&CAMBRIDGE,Mass.--(BUSINESSWIRE)--Takeda(TSE:4502/NYSE:TAK)announcedthattheU.S.FoodandDrugAdministration(FDA)accepteditsNewDrugApplication(NDA)underPriorityReviewforzasocitinib(TAK-279)forthetreatmentofadultswithmoderate-to-severeplaquepsoriasis.Zasocitinibisaninvestigational,next-generation,highlyselectiveandpotentoraltyrosinekinase2(TYK2)inhibitor,whichdemonstratedrapid,durableandconsistentskinclearanceinPhase3plaquepsoriasisstudies.1-3
    Addressingunmetneedsinpsoriasistreatment
    “Despiteprogressinpsoriasiscare,thereremainsaneedforhighlyeffectiveoraltherapiesthatalsoaddressthediverseandoftenchallengingmanifestationsofpsoriasis,includinginvolvementofhigh-impactsiteslikethescalp,”saidAndyPlump,M.D.,Ph.D.,presidentofR&DatTakeda.“OurPhase3datademonstratedrapidanddurableskinclearanceacrossvariouspatienttypesandinhigh-impactandhard-to-treatareas.Basedontheresultsacrossnearly3,000patients,zasocitinibhasthepotentialtobealeadingoraltreatmentoptioninpsoriasis.”
    Phase3clinicaldatasupportingthezasocitinibNDAformoderate-to-severeplaquepsoriasis
    TheNDAfilingissupportedbyacomprehensivedatapackageincludingthepivotalglobalPhase3LATITUDEPsO3001(NCT06088043)and3002(NCT06108544)studies,inwhichallprimaryandrankedsecondaryendpointsweremet.1-2ThesubmissionalsoincludedsupportivedatafromLATITUDEPsO3003(NCT06550076),anopen-labelstudytoevaluatezasocitinib'slong-termsafety,tolerabilityandefficacy.4Zasocitinibdatademonstrated:1-2
    Statisticallysignificantandclinicallymeaningfulimprovementsacrossmultiplemeasuresofskinclearanceandsymptomrelief,withabout70%ofpatientsachievingclearoralmostclearskin(sPGA0/1)atweek16.
    Rapidanddurableskinclearanceforthemajorityofpatients,withclearanceobservedasearlyasweek4andincreasingthroughweek24andfurtherthroughweek52.
    Highlevelsofskinclearanceacrosshard-to-treatandhigh-impactsites,includingthescalp,nails,palmsandsoles,whichcanresultinreducedqualityoflifeforpatients.5
    Zasocitinibwasgenerallywelltolerated,withasafetyprofileconsistentwithpreviousstudies.Nonewsafetysignalswereidentified.
    Nextstepsforzasocitinib
    TheEuropeanMedicinesAgency(EMA)alsoacceptedTakeda’snewmarketingauthorizationapplication(MAA)forzasocitinib,initiatingthereviewprocessforthetreatmentofmoderate-to-severeplaquepsoriasis.Takedaplanstosubmitadditionalapplicationsforplaquepsoriasiswithglobalregulatoryauthoritiestobringzasocitinibtopeoplelivingwithpsoriasisworldwide.
    TheNDAfilinghasnosignificantimpactonthefullyearconsolidatedfinancialforecastforthefiscalyearendingMarch31,2027.
    Q&A:
    WhatspecificdatasupportsthezasocitinibFDAacceptance?
    TheNDAfilingissupportedbythepivotalPhase3LATITUDEPsO3001(NCT06088043)and3002(NCT06108544)studies,inwhichtheco-primaryandall44rankedsecondaryendpointsweremet.1-2,6-7Thestudiesareglobal,multicenter,randomized,double-blind,placebo-andactivecomparator-controlledstudiestoevaluatetheefficacy,safetyandtolerabilityofzasocitinibinadultpatientswithmoderate-to-severeplaquepsoriasis.6-7Co-primaryandselectsecondaryendpointsatweek16included:1-2
    Co-primaryEndpointsandSelectSecondaryEndpointsatWeek16
    LATITUDEPsO3001Results
    LATITUDEPsO3002Results
    staticPhysicianGlobalAssessment(sPGA)0/1
    71%zasocitinibvs11%placeboand32%apremilast(p<0.001)
    BookDermatologyConsults
    69%zasocitinibvs13%placeboand30%apremilast(p<0.001)
    PsoriasisAreaandSeverityIndex(PASI)75
    76%zasocitinibvs12%placeboand37%apremilast(p<0.001)
    71%zasocitinibvs12%placeboand33%apremilast(p<0.001)
    SelectSecondary
    EndpointsatWeek16
    PASI90
    61%zasocitinibvs5%placeboand17%apremilast(p<0.001)
    52%zasocitinibvs4%placeboand16%apremilast(p<0.001)
    sPGA0
    40%zasocitinibvs0.7%placeboand8%apremilast(p<0.001)
    34%zasocitinibvs1%placeboand7%apremilast(p<0.001)
    PASI100
    33%zasocitinibvs0.7%placeboand3%apremilast(p<0.001)
    25%zasocitinibvs1%placeboand4%apremilast(p<0.001)
    Scalp-specificPGA(ssPGA)0/1
    77%zasocitinibvs7%placeboand42%apremilast(p<0.001)
    74%zasocitinibvs13%placeboand30%apremilast(p<0.001)
    NailPsoriasisSeverityIndex(NAPSI),Least-squaresmeanchangefrombaseline
    -7.1zasocitinibvs1.8placebo(p<0.001)
    -8.6zasocitinibvs-1.4placebo(p<0.001)
    Palmoplantar(handsand/orfeetresponse)PGA(hfPGA)0/1*
    71%zasocitinibvs22%placeboand44%apremilast*
    69%zasocitinibvs10%placeboand43%apremilast*
    PASI75atWeek4
    N/A
    17%zasocitinibvs4%forplacebo(p<0.001)
    MostCommonAdverseEvents(≥5%)
    Upperrespiratorytractinfection(10.1%),nasopharyngitis(6.2%)andacne(6.5%),withnonewsafetysignalsidentified**
    *Notamultiplicitycontrolledsecondaryendpoint.Comparisonswithapremilastaredescriptiveandshouldbeinterpretedaccordingly.
    **Samplesizeadjustedincidenceproportionacrossthetwostudies.
    Whencouldzasocitinibbecomeavailabletopatients?
    ZasocitinibiscurrentlyunderFDAPriorityReview,withadecisionanticipatedinthefirstquarterof2027.Ifapproved,zasocitinibcouldbecomeavailabletoappropriatepatientsafterFDAapproval.
    BookDermatologyConsults
    AboutPlaquePsoriasis
    Psoriasisisachronic,systemicimmune-mediatedinflammatorydiseasecharacterizedbyitchy,painful,disfiguringanddisablingskinlesionsthatimpactone’sphysical,emotionalandpsychologicalwellbeing.7,8,14Globally,anestimated66.4millionpeoplearelivingwithpsoriasis,andabout80-90%ofthosehaveplaquepsoriasis.15-17Persistentitch,theappearanceandlocationofskinlesions—especiallyinhighlyvisibleorhigh-impactsites—andrelatedcomorbidities,likepsoriaticarthritis,playamajorroleinreducingqualityoflifeandcanleadtosignificantimpactsondailyliving.8,12-14Psoriasisisalsoaheterogeneousdiseasedrivenbycomplex,interconnectedimmunepathways,geneticsandenvironmentalfactorsthatdifferacrosspatientsandovertime,leadingtovariabilityindiseasecourse,symptomsandtreatmentresponse.18-22
    AboutZasocitinib(TAK-279)
    Zasocitinibisaninvestigational,next-generation,highlyselectiveandpotentoralTYK2inhibitorthatmaintains24-hourinhibitionofIL-23plusothercoredisease-drivingimmunepathways.23-27Ithasthepotentialtobealeadingoraltreatmentoptionforpeoplelivingwithpsoriasisthatmaydeliverrapidanddurableskinclearanceinaconvenientonce-dailypill.1-2Zasocitinibhasmorethan1-million-foldgreaterselectivityforTYK2comparedtootherJAKenzymes,whichcouldmaximizeTYK2inhibitionwithoutimpactingJAK1,2and3signaling,basedoninvitrodata.23-24TakedaiscurrentlyevaluatingthesafetyandefficacyofzasocitinibinPhase3studiesinpsoriaticarthritisandPhase2studiesinCrohn’sdisease,ulcerativecolitis,vitiligoandhidradenitissuppurativa.28-33Zasocitinibisaninvestigationalcompoundthathasnotbeenapprovedforusebyanyregulatoryauthority.
    AboutTyrosineKinase2(TYK2)Inhibitors
    TYK2isacentralmediatorofcoreinflammatorypathwaysinpsoriasis—IL-23/IL-17axisandtypeIinterferonsignaling—makingitapromisingtargetasinhibitionofasinglepathwaymaynotfullycontroldiseaseforeverypatient.22,26,34TYK2isanintracellularenzymeandmemberoftheJanuskinase(JAK)proteinfamily.22-23However,TYK2isdistinctfromJAK1,2and3asitprimarilyregulatesimmuneresponses,whereasJAK1,2and3regulatebroaderbiologicalprocessessuchaslipidmetabolismandhematopoiesis.22-23HighlyselectiveallostericinhibitionofTYK2,withminimalinhibitionofJAK1,2and3,isapromisingtherapeuticapproachtotargetimmune-mediatedinflammation.27
    AboutthePhase3LATITUDEPsO3001and3002Studies
    ThePhase3LATITUDEPsO3001(NCT06088043)and3002(NCT06108544)studiesareglobal,multicenter,randomized,double-blind,placebo-andactivecomparator-controlledstudiestoevaluatetheefficacy,safetyandtolerabilityofzasocitinibinadultpatientswithmoderate-to-severeplaquepsoriasis.6-7Thestudieswereconductedin21countries,withLATITUDEPsO3001enrolling693participantsandLATITUDEPsO3002enrolling1,108participants,respectively.Theco-primaryendpointsweretheproportionofzasocitinib-treatedpatientsachievingsPGA0/1andPASI75responsecomparedtoplaceboatweek16.6-7Rankedsecondaryendpointsincludedcomparisonsversusplacebo(week16)andapremilast(week16andweek24).6-7
    AboutthePhase3LATITUDEPsO3003Study
    TheLATITUDEPsO3003(NCT06550076)studyisaPhase3,multicenter,open-labelstudyevaluatingthelong-termsafety,tolerabilityandefficacyofzasocitinibinadultswithmoderate-to-severeplaquepsoriasis.4Thestudyenrolledapproximately2,100participantsandconsistsoftwoparts.4InPartA(denovocohort),adultpatientswhohadnotbeenexposedtozasocitinibbeforereceivedzasocitinib30mgoncedailyforupto52weeks.4PatientswhocompletedPartAorthetreatmentperiodinthePhase3LATITUDEPsO3001(NCT06088043)and3002(NCT06108544)studiesreceivedzasocitinibforupto156weeksinPartB.4Theprimaryendpointwasthenumberofzasocitinib-treatedpatientswithtreatment-emergentandseriousadverseevents.4Secondaryendpointsweretheproportionofzasocitinib-treatedpatientsachievingsPGA0/1andPASI75response.4
    AboutTakeda
    Takedaisfocusedoncreatingbetterhealthforpeopleandabrighterfuturefortheworld.Weaimtodiscoveranddeliverlife-transformingtreatmentsinourcoretherapeuticandbusinessareas,includinggastrointestinalandinflammation,rarediseases,plasma-derivedtherapies,oncology,neuroscienceandvaccines.Togetherwithourpartners,weaimtoimprovethepatientexperienceandadvanceanewfrontieroftreatmentoptionsthroughourdynamicanddiversepipeline.Asaleadingvalues-based,R&D-drivenbiopharmaceuticalcompanyheadquarteredinJapan,weareguidedbyourcommitmenttopatients,ourpeopleandtheplanet.Ouremployeesinapproximately80countriesandregionsaredrivenbyourpurposeandaregroundedinthevaluesthathavedefinedusformorethantwocenturies.Formoreinformation,visitwww.takeda.com.
    ImportantNotice
    Forthepurposesofthisnotice,“pressrelease”meansthisdocument,anyoralpresentation,anyquestion-and-answersessionandanywrittenororalmaterialdiscussedordistributedbyTakedaPharmaceuticalCompanyLimited(“Takeda”)regardingthisrelease.Thispressrelease(includinganyoralbriefingandanyquestion-and-answerinconnectionwithit)isnotintendedto,anddoesnotconstitute,representorformpartofanyoffer,invitationorsolicitationofanyoffertopurchase,otherwiseacquire,subscribefor,exchange,sellorotherwisedisposeof,anysecuritiesorthesolicitationofanyvoteorapprovalinanyjurisdiction.Nosharesorothersecuritiesarebeingofferedtothepublicbymeansofthispressrelease.NoofferingofsecuritiesshallbemadeintheUnitedStatesexceptpursuanttoregistrationundertheU.S.SecuritiesActof1933,asamended,oranexemptiontherefrom.Thispressreleaseisbeinggiven(togetherwithanyfurtherinformationwhichmaybeprovidedtotherecipient)ontheconditionthatitisforusebytherecipientforinformationpurposesonly(andnotfortheevaluationofanyinvestment,acquisition,disposaloranyothertransaction).Anyfailuretocomplywiththeserestrictionsmayconstituteaviolationofapplicablesecuritieslaws.
    FindPrescriptionSavings
    ThecompaniesinwhichTakedadirectlyandindirectlyownsinvestmentsareseparateentities.Inthispressrelease,“Takeda”issometimesusedforconveniencewherereferencesaremadetoTakedaanditssubsidiariesingeneral.Likewise,thewords“we”,“us”and“our”arealsousedtorefertosubsidiariesingeneralortothosewhoworkforthem.Theseexpressionsarealsousedwherenousefulpurposeisservedbyidentifyingtheparticularcompanyorcompanies.
    Forward-LookingStatements
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    MedicalInformation
    Thispressreleasecontainsinformationaboutproductsthatmaynotbeavailableinallcountries,ormaybeavailableunderdifferenttrademarks,fordifferentindications,indifferentdosages,orindifferentstrengths.Nothingcontainedhereinshouldbeconsideredasolicitation,promotionoradvertisementforanyprescriptiondrugsincludingtheonesunderdevelopment.
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