“药王”修美乐（Humira）欧盟再添新适应症——儿科慢性斑块型银屑病

2015年4月2日讯/生物谷BIOON/--在2014年的药品销售排行榜中，来自生物技术巨头艾伯维（AbbVie）的修美乐（Humira）以125亿美元的绝对优势，继续稳坐全球“药王”宝座，相比上一年的107亿美元增长17.7%。花旗银行分析师曾预测，Humira的销售将继续上涨，到2016年专利到期时达到其销售峰值160亿美元。随后该药将受生物仿制药冲击销售开始下跌，但业界认为，生物仿制药对Humira的影响有限，到2020年该药的年销售额仍会高达148亿美元。
近日，Humira在欧盟监管方面再度收获新适应症，这将进一步助推该药的全球销售增长。根据艾伯维官网信息，欧盟已批准Humira（修美乐，通用名：adalimumab，阿达木单抗）用于对局部治疗或光疗反应不足或不适合的4岁及以上重度慢性斑块型银屑病儿童和青少年患者的治疗。此次批准，使Humira成为欧洲用于该群体的首个生物制剂，标志着该群体临床治疗的一个重大里程碑。
Humira新适应症的获批，是基于一项III期临床研究的结果，相关数据将提交至即将召开的科学会议。Humira于2003年上市，目前已获全球80多个国家批准，在全球范围内获批的适应症达到了11个之多。当前正在接受Humira治疗的全球患者总数超过85万人。
据世界卫生组织（WHO）估计，儿科银屑病在儿童群体中的发病率约为0.7%。慢性斑块型银屑病是一种慢性自身免疫性疾病，特征为皮肤细胞的快速过多积累，形成厚厚的炎症斑块、鳞屑状皮肤。儿科银屑病与成人银屑病具有相似的特征，但在儿童中，银屑病皮损通常更小、更薄、斑块更少。儿科银屑病临床治疗时，除了考虑治疗方面的挑战，还要考虑疾病对儿童造成的显著情感和心理问题。
在欧盟，目前Humira已获批的适应症包括：中度至重度类风湿性关节炎、强直性脊柱炎、中度至重度斑块型银屑病、活动性进展性银屑病关节炎、中度至重度活动性克罗恩病、中度至重度活动性溃疡性结肠炎。儿科方面，Humira已获批的适应症包括：附着点炎相关关节炎(ERA)、重度斑块型银屑病、重度克罗恩病、活动性幼年特发性关节炎。
英文原文：ABBVIESHUMIRA®(ADALIMUMAB)APPROVEDBYEUROPEANCOMMISSIONTOTREATCHILDRENANDADOLESCENTSWITHSEVERECHRONICPLAQUEPSORIASIS
–HUMIRAistheonlyBiologicApprovedinEuropeforChildrenandAdolescentsfromFourYearsofAgewithSevereChronicPlaquePsoriasis–
NORTHCHICAGO,Illinois,April1,2015/PRNewswire/--AbbVie(NYSE:ABBV)announcedtodaythattheEuropeanCommission(EC)hasgrantedmarketingauthorizationforHUMIRA®(adalimumab)forthetreatmentofseverechronicplaquepsoriasisinchildrenandadolescentsfromfouryearsofagewhohavehadaninadequateresponsetoorareinappropriatecandidatesfortopicaltherapyandphototherapies.WiththeECdecision,HUMIRAnowhasapprovalforuseinthisindicationinallmemberstatesoftheEuropeanUnion.
"Severaltreatmentshavebeenshowntobeeffectiveinsubgroupsofpatientswithpediatricpsoriasis.However,alimitedbodyofsupportingdataisavailable.Theapprovalofadalimumabisanimportantmilestoneinparticularforchildrenwithseverediseasebecauseitextendsthearmamentariumofthephysicianswhoareworkingtoreducetheburdenofthischronicdiseaseinthissensitiveyoungpatientpopulation,"saidMariekeM.B.Seyger,MD,PhD,AssociateProfessorofDermatology,RadboudUniversityMedicalCenterinNijmegen,Netherlands.
ThemarketingauthorizationisbasedonthepositiveresultsofaPhase3study,whichwillbepresentedatanupcomingmedicalmeeting.Sincefirstgainingapproval12yearsago,HUMIRAhasbeenapprovedinmorethan87countries.Itiscurrentlybeingusedtotreatmorethan851,083patientsworldwide1across11globallyapprovedindications.2
"WiththeapprovalfromtheEuropeanCommission,HUMIRAisnowtheonlybiologicapprovedinEuropetotreatchildrenwiththisconditionstartingatfouryearsofage,offeringanimportantnewoptionforphysicianstreatingpediatricplaquepsoriasis,"saidMichaelSeverino,M.D.,executivevicepresident,researchanddevelopmentandchiefscientificofficer,AbbVie."ThisnewindicationcontributestotheincreasinglybroadspectrumofindicationsforHUMIRA,andsupportsitsstrongrecordofefficacyandsafetyintreatingpediatricpopulationswhoaremanagingchallengingchronicdiseases."
AboutPediatricChronicPlaquePsoriasisAccordingtoestimatesfromtheWorldHealthOrganization,pediatricpsoriasisoccursin0.70percentofthepediatricpopulation,3withnosignificantdifferencebygender.4Thechronicautoimmunediseaseischaracterizedbytherapidandexcessiveaccumulationofskincells,whichformthickpatchesofinflamed,scalyskin.5Pediatricpsoriasishassimilarcharacteristicstoadultpsoriasis,butinchildren,thepsoriaticlesionsaretypicallysmaller,thinner,andlessscaly.4Beyondthephysicalchallengesofmanagingthechronicskindisorder,itisalsoconsideredtohavesignificantemotionalandpsychologicaleffects.6
HUMIRAEUTherapeuticIndications2HUMIRAisapprovedforuseinmoderatetosevererheumatoidarthritis,ankylosingspondylitis,moderatetosevereplaquepsoriasis,activeandprogressivepsoriaticarthritis,moderatetoseverelyactiveCrohnsDiseaseandmoderatetoseverelyactiveulcerativecolitis.HUMIRAisapprovedinpediatricpatientsforuseinenthesitis-relatedarthritis,severeplaquepsoriasis,severeCrohnsdisease,andactivejuvenileidiopathicarthritisinpatientswhohavehadinadequateresponsetopriortherapy.SeeSmPCforfullindication.
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