后生可畏，拜耳眼科药物Eylea第4个适应症获欧盟批准

2015年2月27日讯/生物谷BIOON/--拜耳（Bayer）及合作伙伴再生元（Regeneron）近日宣布，眼科药物（aflibercept，阿柏西普注射液）在欧盟收获第4个适应症。欧盟委员会（EC）已批准Eylea用于视网膜静脉阻塞继发黄斑水肿（RVO-ME）的治疗，包括视网膜分支静脉阻塞继发黄斑水肿（BRVO-ME）及先前已获批的视网膜中央静脉阻塞继发黄斑水肿（CRVO-ME）。建议的治疗方法为：起始治疗时每周注射一次直至达到最大视力和/或无疾病活动迹象；之后，以一种“治疗-延长”方案继续治疗，逐渐延长治疗时间间隔，以维持稳定的视觉和/或解剖学结果。在欧盟，Eylea已获批的另外3个适应症为：湿性年龄相关性黄斑变性（wet-AMD），视网膜中央静脉阻塞继发黄斑水肿（CRVO-ME），糖尿病性黄斑水肿（DME）。
Eylea新适应症的获批，基于一项为期52周的双盲、随机、主动控制III期研究（VIBRANT）的结果。该研究在视网膜分支静脉阻塞（BRVO）继发黄斑水肿（ME）患者中开展，Eylea治疗组每月注射2mg剂量Eylea，对照组接受激光光凝治疗。数据表明，在研究的24周，Eylea治疗组有更高比例的患者最佳矫正视力（BCVA）取得了至少15个字母的改善（53%vs27%，p＜0.001），达到了研究的主要终点。此外，Eylea治疗组BCVA从基线平均改善达17.0个字母，对照组为6.9个字母，达到了研究的关键次要终点（p＜0.0001）。
目前，眼科治疗领域，拜耳正与罗氏及诺华展开激烈竞争。Eylea于2011年上市，但近年来发展势头迅猛，适应症个数及全球销售一再刷新并连续多次超过业界预期，已对罗氏和诺华眼科药物Lucentis（2006年上市）形成严峻挑战。此外，根据拜耳2014年10月公布的一项研究，用于治疗糖尿病性黄斑水肿（DME）时，Eylea击败了Lucentis和Avastin，该项研究结果使得Eylea在DME领域更具影响力。
不过，本月中旬，Lucentis率先赢得FDA祝福，拿下糖尿病性视网膜病变（DR）适应症，标志着对Eylea强有力的反击，该适应症也是Lucentis在美国市场收获的第4个适应症。其他3个适应症分别为：糖尿病性黄斑水肿（DME，2006年）、视网膜静脉阻塞继发黄斑水肿（RVO-ME，2010年）和湿性年龄相关性黄斑变性（wet-AMD，2012）。
英文原文：BayerReceivesEUApprovalforEYLEAfortheTreatmentofRetinalVeinOcclusion
Berlin,February26,2015–BayerHealthCareannouncedtodaythatEYLEA?(afliberceptsolutionforinjectionintotheeye)hasbeenapprovedbytheEuropeanCommissionforthetreatmentofpatientswithvisualimpairmentduetomacularedemasecondarytoretinalveinocclusion(RVO).Thisnewindicationincludesmacularedemafollowingbranchretinalveinocclusion(BRVO)inadditiontothepreviously-approvedindicationofmacularedemasecondarytocentralretinalveinocclusioninadults(CRVO).Therecommendedtreatmentapproachistoinitiatetherapywithoneinjectionpermonthuntilmaximumvisualacuityisachievedand/ortherearenosignsofdiseaseactivity.Treatmentmaythenbecontinuedwitha“treatandextend”regimenwithgraduallyincreasedtreatmentintervalstomaintainstablevisualand/oranatomicoutcomes.
“RVOisachronicdiseasethatrequiresearlyandongoingmanagementtoobtainthebestpossiblevision,whichiscriticalasmanypatientsarestillofworking-age,”saidDr.JoergMoeller,MemberoftheBayerHealthCareExecutiveCommitteeandHeadofGlobalDevelopment.“Thisnewtherapeuticapproachallowsphysicianstoindividualizetherapyforeachpatient,maximizingtimebetweentreatments.Thisreducesthetreatmentburdenonpatients,physiciansandtheirclinics."
Theapprovalisbasedonpositiveresultsfromthedouble-masked,randomized,active-controlledphase3VIBRANTstudyinpatientswithvisualimpairmentduetomacularedemasecondarytoBRVO.Theprimaryendpointwastheproportionofsubjectswhogainedatleast15lettersinbestcorrectedvisualacuity(BCVA)frombaselineatweek24,asmeasuredontheEarlyTreatmentDiabeticRetinopathyScale(ETDRS)eyechart,astandardchartusedinresearchtomeasurevisualacuity.Morethanhalfofthepatientswhoweretreatedwithafliberceptsolutionforinjectiongainedatleastthreelinesofvision.
AboutRetinalVeinOcclusionRetinalveinocclusion(RVO)includesbranchretinalveinocclusion(BRVO)andcentralretinalveinocclusion(CRVO).RVOisachroniceyeconditionthatcanleadtosuddenvisionlossandissecondonlytodiabeticretinopathyasthemostfrequentcauseofvisuallossfromdiseasesaffectingthebloodvesselsoftheretina.WhileeachpatientexperiencesRVOdifferently,allpatientsareatriskforvisionlosswhichcanimpacttheirabilitytoparticipateineverydayactivitiesandmaycausesignificantfinancialburdentopatients,theirfamiliesaswellasbroadersociety.RVOhasasignificantglobalimpactwithanestimated16.4millionpeopleaffectedworldwide,includingaround13.9millionwithBRVOand2.5millionwithCRVO.
RVOistheresultofablockageinabloodvesseloftheretina,thelightsensitivepartoftheeye.InCRVO,theblockageoccursinthemainretinalveinattheopticnerve.InBRVO,theblockageoccursinoneofthebranchretinalveins.Ifablockageinanyoftheretinalveins(centralorbranch)isnotresolved,itcanresultinanumberofcomplications.ThemostcommonreasonforvisionimpairmentinpatientswithRVOismacularedema,swellingofthemacula,whichisthecentralportionoftheretinaresponsibleforseeingfinedetails.
AboutVEGFandEYLEA?(afliberceptsolutionforinjectionintotheeye)VascularEndothelialGrowthFactor(VEGF)isanaturallyoccurringproteininthebody.Itsnormalroleinahealthyorganismistotriggerformationofnewbloodvessels(angiogenesis)supportingthegrowthofthebodystissuesandorgans.Itisalsoassociatedwiththegrowthofabnormalnewbloodvesselsintheeye,whichexhibitabnormalincreasedpermeabilitythatleadstoedema.
Afliberceptsolutionforinjectionisarecombinantfusionprotein,consistingofportionsofhumanVEGFreceptors1and2extracellulardomainsfusedtotheFcportionofhumanIgG1andformulatedasaniso-osmoticsolutionforintravitrealadministration.AfliberceptactsasasolubledecoyreceptorthatbindsVEGF-Aandplacentalgrowthfactor(PlGF)andtherebycaninhibitthebindingandactivationoftheircognateVEGFreceptors.
AfliberceptsolutionforinjectionintotheeyehasbeenapprovedunderthebrandnameEYLEA?inmorethan80countriesforthetreatmentofpatientswithneovascularage-relatedmaculardegeneration(wetAMD)andaround40countriesforthetreatmentofvisualimpairmentduetomacularedemasecondarytocentralretinalveinocclusion.EYLEAisalsoapprovedforthetreatmentofdiabeticmacularedema(DME)inover40countries.OverthreemilliondosesofEYLEAhavebeenadministeredsincelaunchworldwide.InJapan,EYLEAhasbeenadditionallyapprovedforthetreatmentofmyopicchoroidalneovascularizationandanapplicationformarketingauthorizationhasalsobeensubmittedforthetreatmentofmacularedemasecondarytoBRVO.IntheU.S.,EYLEAisalreadyapprovedforthetreatmentofRVO.
BayerHealthCareandRegeneronPharmaceuticals,Inc.arecollaboratingontheglobaldevelopmentofEYLEA.RegeneronmaintainsexclusiverightstoEYLEAintheU.S.BayerHealthCarelicensedtheexclusivemarketingrightsoutsidetheU.S.,wherethecompaniesshareequallytheprofitsfromsalesofEYLEA,exceptforJapanwhereRegeneronreceivesapercentageofnetsales.
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