[全球医生组织北京代表处]|资讯|“人民的希望”瑞德西韦正式获FDA紧急授权应用 5月1日

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5月1日，美国FDA根据“紧急授权应用”(EUA)条款，正式批准了吉利德公司研制的抗病毒药“瑞姆西韦”用于治疗新冠病毒Covid-19感染患者(包括成人和儿童) 。
正如业界专家评述“这是板上钉钉的事儿了” 。
无论如何，该药的安全性至少比羟氯喹要好得多。羟氯喹是上市用药，临床治疗疟疾或风湿性关节炎等，但用于治疗新冠肺炎或Covid-19感染患者总是让人心里不踏实。
然而，，这其中的客观原因是什么？
WHO有关负责人也对此药的临床疗效，或可否应用于治疗新冠肺炎/Covid-19病毒感染给出了不知可否的答复。
简单讲，同样规范的临床试验设计(随机、双盲安慰剂对照) ，如果临床疗效评估终点指标和该药应用紧急状况(目前疫情急迫窘况）不同，也可能最终左右了FDA审评专家给出了【绿灯】“紧急授权应用” 。

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FDA在其官方网站上发表的声明如下：
“FDA’semergencyauthorizationofremdesivir,twodaysaftertheNationalInstitutesofHealth’sclinicaltrialshowedpromisingresults,isasignificantstepforwardinbattlingCOVID-19andanotherexampleoftheTrumpAdministrationmovingasquicklyaspossibletousesciencetosavelives,”saidHHSSecretaryAlexAzar.
“NIH,FDA,andscientistsacrossAmericaandaroundtheworldhaveworkedtirelesslywithpatientstogetusthisnewpotentialtreatmentforCOVID-19.
TheseamlesscooperationbetweengovernmentandprivateindustryunderthePresident’sall-of-AmericaapproachtoCOVID-19isgettingtreatmentoptionstopatientsinrecordtime.”
TheemergencyuseauthorizationallowsforremdesivirtobedistributedintheU.S.andadministeredintravenouslybyhealthcareproviders,asappropriate,totreatsuspectedorlaboratory-confirmedCOVID-19inadultsandchildrenhospitalizedwithseveredisease.
Severediseaseisdefinedaspatientswithlowbloodoxygenlevelsorneedingoxygentherapyormoreintensivebreathingsupportsuchasamechanicalventilator.
“Fromdayone,theFDAhasbeencommittedtoexpeditingthedevelopmentandavailabilityofpotentialCOVID-19treatments.Today’sactionisanimportantstepinoureffortstocollaboratewithinnovatorsandresearcherstoprovidesickpatientstimelyaccesstonewtherapieswhereappropriate,whileatthesametimesupportingresearchtofurtherevaluatewhethertheyaresafeandeffective,”saidFDACommissionerStephenM.Hahn,M.D.
“There’stremendousinterestamongallpartiestoidentifyandarmourselveswithmedicinestocombatCOVID-19,andthroughourCoronavirusTreatmentAccelerationProgram,theFDAisworkingaround-the-clockandusingeverytoolatourdisposaltospeedtheseefforts.”
Basedonevaluationoftheemergencyuseauthorizationcriteriaandthescientificevidenceavailable,itwasdeterminedthatitisreasonabletobelievethatremdesivirmaybeeffectiveintreatingCOVID-19,andthat,giventherearenoadequate,approved,oravailablealternativetreatments,theknownandpotentialbenefitstotreatthisseriousorlife-threateningviruscurrentlyoutweightheknownandpotentialrisksofthedrug’suse.
TheEUAalsorequiresthatfactsheetsthatprovideimportantinformationaboutusingremdesivirintreatingCOVID-19bemadeavailabletohealthcareprovidersandpatients,includingdosinginstructions,potentialsideeffectsanddruginteractions.