Fasenra | European Medicines Agency - European Union

The active substance in Fasenra, benralizumab, is a monoclonal antibody (a type of protein) designed to attach to receptors (targets) called interleukin-5 ... 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Overview Fasenraisanasthmamedicineusedtotreatadultswithaparticulartypeofasthmacalledeosinophilicasthma.Itisusedasanadditionaltreatmentinadultswithsevereasthmathatisnotadequatelycontrolledbyacombinationofhigh-doseinhaledcorticosteroidsplusmedicinescalledlong-actingbeta-agonists. Fasenracontainstheactivesubstancebenralizumab. Expandsection Collapsesection HowisFasenraused? Fasenraisavailableasasolutionforinjectioninpre-filledsyringesandpre-filledpens.Itcanonlybeobtainedwithaprescriptionandtreatmentshouldbestartedbydoctorswithexperienceinthediagnosisandtreatmentofsevereasthma.Therecommendeddoseis30mginjectedundertheskinofthethighsorbellyevery4weeksforthefirst3doses,andevery8weeksafterwards.Iftheinjectionisgivenbyadoctororcarer,itcanalsobegivenundertheskinoftheupperarm.Ifagreedwiththetreatingdoctor,patientsalreadyusingFasenraandwithnohistoryofsevereallergicreactions,ortheircarers,caninjectFasenrathemselvesafterpropertraining,includingonhowtowatchoutforsignsandsymptomsofallergicreactions.Fasenrashouldbegivenforaslongasthepatientbenefitsfromit,anddoctorsshouldre-assessatleastonceayearwhethertreatmentshouldbecontinued.FormoreinformationaboutusingFasenra,seethepackageleafletorcontactyourdoctororpharmacist. HowdoesFasenrawork? Ineosinophilicasthma,symptomsareassociatedwithhavingtoomanyofatypeofwhitebloodcellcalledeosinophilsinthebloodandinphlegminthelungs.TheactivesubstanceinFasenra,benralizumab,isamonoclonalantibody(atypeofprotein)designedtoattachtoreceptors(targets)calledinterleukin-5receptorsonthesurfaceofeosinophils.Byattachingtointerleukin-5receptors, Fasenraactivatestheimmunesystem(thebody’snaturaldefences)tokilltheeosinophilsinthebloodandlungs.Thishelpstoreduceinflammation,resultinginareductioninasthmaattacksandimprovementofsymptoms. WhatbenefitsofFasenrahavebeenshowninstudies? Fasenrawasshowntoreducethenumberofexacerbations(flare-ups)ofasthmaduringtreatmentin2mainstudiesinvolvingatotalof2,511patientswitheosinophilicasthmathatwasnotadequatelycontrolledbyacombinationofhigh-doseinhaledcorticosteroidsandlong-actingbeta-agonists.Amongpatientswiththehighestnumberofbloodeosinophilsbeforetreatment,thenumberofsevereflare-upsperyearwas0.66inpatientstreatedwithFasenra(givenevery4weeksforthefirst3dosesandevery8weeksafterwards),comparedwith1.14inpatientsgivenplacebo(adummytreatment).Athirdstudyinvolving220patientsshowedthatmorepatientsgivenFasenrahadtheirconditionimprovedtotheextentthattheycouldreducetheirdoseofcorticosteroidsbyanaverageof75%comparedwith25%ofthosegivenplacebo. WhataretherisksassociatedwithFasenra? ThemostcommonsideeffectswithFasenra(whichmayaffectupto1in10people)includeheadacheandpharyngitis(sorethroat).ForthefulllistofsideeffectsandrestrictionsofFasenra,seethepackageleaflet. WhyisFasenraauthorisedintheEU? Fasenrahasbeenshowntobemoreeffectivethanplaceboatreducingthenumberofasthmaflare-upsandtheneedforcorticosteroidtreatment.Themedicineiswelltoleratedwithfewsideeffects.TheEuropeanMedicinesAgencythereforedecidedthatFasenra’sbenefitsaregreaterthanitsrisksandrecommendedthatitbeapprovedforuseintheEU. WhatmeasuresarebeingtakentoensurethesafeandeffectiveuseofFasenra? RecommendationsandprecautionstobefollowedbyhealthcareprofessionalsandpatientsforthesafeandeffectiveuseofFasenrahavebeenincludedinthesummaryofproductcharacteristicsandthepackageleaflet.Asforallmedicines,dataontheuseofFasenraarecontinuouslymonitored.SideeffectsreportedwithFasenraarecarefullyevaluatedandanynecessaryactiontakentoprotectpatients. OtherinformationaboutFasenra FasenrareceivedamarketingauthorisationvalidthroughouttheEUon8January2018. Listitem Fasenra:EPAR-Medicineoverview (PDF/68.26KB) Firstpublished: 08/03/2018 Lastupdated: 27/08/2019 EMA/408482/2019 Availablelanguages(22) Bulgarian (PDF/117.84KB) (PDF/117.84KB) Croatian (PDF/109.22KB) (PDF/109.22KB) Czech (PDF/113.91KB) (PDF/113.91KB) Danish (PDF/94.53KB) (PDF/94.53KB) Dutch (PDF/95.79KB) (PDF/95.79KB) Estonian (PDF/92.93KB) (PDF/92.93KB) Finnish (PDF/94.35KB) (PDF/94.35KB) French (PDF/104.04KB) (PDF/104.04KB) German (PDF/96.11KB) (PDF/96.11KB) Greek (PDF/125.33KB) (PDF/125.33KB) Hungarian (PDF/108.67KB) (PDF/108.67KB) Italian (PDF/95.54KB) (PDF/95.54KB) Latvian (PDF/113.06KB) (PDF/113.06KB) Lithuanian (PDF/112.87KB) (PDF/112.87KB) Maltese (PDF/114.05KB) (PDF/114.05KB) Polish (PDF/113.82KB) (PDF/113.82KB) Portuguese (PDF/95.67KB) (PDF/95.67KB) Romanian (PDF/112.08KB) (PDF/112.08KB) Slovak (PDF/112.87KB) (PDF/112.87KB) Slovenian (PDF/108.14KB) (PDF/108.14KB) Spanish (PDF/95.66KB) (PDF/95.66KB) Swedish (PDF/94.28KB) (PDF/94.28KB) ThisEPARwaslastupdatedon28/09/2022 Authorisationdetails Productdetails Name Fasenra Agencyproductnumber EMEA/H/C/004433 Activesubstance benralizumab Internationalnon-proprietaryname(INN)orcommonname benralizumab Therapeuticarea(MeSH) Asthma Anatomicaltherapeuticchemical(ATC)code R03DX10 Publicationdetails Marketing-authorisationholder AstraZenecaAB Revision 9 DateofissueofmarketingauthorisationvalidthroughouttheEuropeanUnion 08/01/2018 Contactaddress 15185Sodertalje Sweden Productinformation 15/09/2022Fasenra-EMEA/H/C/004433-R/0044 Listitem Fasenra:EPAR-ProductInformation (PDF/1.52MB) (updated) Firstpublished: 08/03/2018 Lastupdated: 28/09/2022 Availablelanguages(24) Bulgarian (PDF/1.58MB) (PDF/1.58MB) Croatian (PDF/1.21MB) (PDF/1.21MB) Czech (PDF/1.51MB) (PDF/1.51MB) Danish (PDF/1.24MB) (PDF/1.24MB) Dutch (PDF/1.58MB) (PDF/1.58MB) Estonian (PDF/1.51MB) (PDF/1.51MB) Finnish (PDF/1.22MB) (PDF/1.22MB) French (PDF/1.24MB) (PDF/1.24MB) German (PDF/1.26MB) (PDF/1.26MB) Greek (PDF/1.28MB) (PDF/1.28MB) Hungarian (PDF/1.31MB) (PDF/1.31MB) Icelandic (PDF/1.5MB) (PDF/1.5MB) Italian (PDF/1.55MB) (PDF/1.55MB) Latvian (PDF/1.53MB) (PDF/1.53MB) Lithuanian (PDF/1.25MB) (PDF/1.25MB) Maltese (PDF/1.63MB) (PDF/1.63MB) Norwegian (PDF/1.52MB) (PDF/1.52MB) Polish (PDF/1.22MB) (PDF/1.22MB) Portuguese (PDF/1.23MB) (PDF/1.23MB) Romanian (PDF/1.51MB) (PDF/1.51MB) Slovak (PDF/1.22MB) (PDF/1.22MB) Slovenian (PDF/1.53MB) (PDF/1.53MB) Spanish (PDF/1.57MB) (PDF/1.57MB) Swedish (PDF/1.52MB) (PDF/1.52MB) Productinformationdocumentscontain:summaryofproductcharacteristics(annexI);manufacturingauthorisation holderresponsibleforbatchrelease(annexIIA);conditionsofthemarketingauthorisation(annexIIB);labelling(annexIIIA);packageleaflet(annexIIIB).Youcanfindproductinformationdocumentsforcentrallyauthorisedhumanmedicinesonthiswebsite.ForcentrallyauthorisedveterinarymedicinesauthorisedorupdatedfromFebruary2022,seetheVeterinaryMedicinesInformationwebsite. Listitem Fasenra:EPAR-AllAuthorisedpresentations (PDF/22.99KB) Firstpublished: 08/03/2018 Lastupdated: 27/08/2019 Availablelanguages(24) Bulgarian (PDF/24.29KB) (PDF/24.29KB) Croatian (PDF/21.84KB) (PDF/21.84KB) Czech (PDF/23.48KB) (PDF/23.48KB) Danish (PDF/24.66KB) (PDF/24.66KB) Dutch (PDF/22.55KB) (PDF/22.55KB) Estonian (PDF/26.09KB) (PDF/26.09KB) Finnish (PDF/39.62KB) (PDF/39.62KB) French (PDF/22.61KB) (PDF/22.61KB) German (PDF/23.78KB) (PDF/23.78KB) Greek (PDF/28.66KB) (PDF/28.66KB) Hungarian (PDF/43.08KB) (PDF/43.08KB) Icelandic (PDF/23.92KB) (PDF/23.92KB) Italian (PDF/21.04KB) (PDF/21.04KB) Latvian (PDF/23.3KB) (PDF/23.3KB) Lithuanian (PDF/23KB) (PDF/23KB) Maltese (PDF/23.31KB) (PDF/23.31KB) Norwegian (PDF/23.45KB) (PDF/23.45KB) Polish (PDF/27.93KB) (PDF/27.93KB) Portuguese (PDF/23.73KB) (PDF/23.73KB) Romanian (PDF/26.68KB) (PDF/26.68KB) Slovak (PDF/23.34KB) (PDF/23.34KB) Slovenian (PDF/21.75KB) (PDF/21.75KB) Spanish (PDF/22.5KB) (PDF/22.5KB) Swedish (PDF/22.96KB) (PDF/22.96KB) Pharmacotherapeuticgroup Drugsforobstructiveairwaydiseases Therapeuticindication Fasenraisindicatedasanaddonmaintenancetreatmentinadultpatientswithsevereeosinophilicasthmainadequatelycontrolleddespitehigh-doseinhaledcorticosteroidspluslongactingβagonists. Assessmenthistory Changessinceinitialauthorisationofmedicine Listitem Fasenra:EPAR-Proceduralstepstakenandscientificinformationafterauthorisation (PDF/164.1KB) (updated) Firstpublished: 18/05/2018 Lastupdated: 28/09/2022 Listitem Fasenra-H-C-004433-P46:EPAR-AssessmentReport (PDF/1.22MB) Adopted Firstpublished: 16/10/2018 EMA/622026/2018 Initialmarketing-authorisationdocuments Listitem Fasenra:EPAR-Publicassessmentreport (PDF/2.39MB) Adopted Firstpublished: 08/03/2018 Lastupdated: 08/03/2018 EMA/780390/2017 Listitem CHMPsummaryofpositiveopinionforFasenra (PDF/120.68KB) Adopted Firstpublished: 10/11/2017 Lastupdated: 10/11/2017 EMA/727638/2017 News MeetinghighlightsfromtheCommitteeforMedicinalProductsforHumanUse(CHMP)6-9November2017 10/11/2017 Relatedcontent Fasenra:Paediatricinvestigationplan Fasenra:Paediatricinvestigationplan Fasenra:Paediatricinvestigationplan Howusefulwasthispage? 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