2018年FDA新药审评报告（英文版）.pdf

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1、CDERNewDrugsProgram:2018UpdateKhushbooSharma,MBA,RACChiefofStaff(Acting)OfficeofNewDrugs,CDER/FDAFDA/CMSSummitDecember11th,2018HousekeepingDataandanalysespresentedtoreflectlatestinformation,althoughusualQCforofficialFDAreportshasnotoccurred.Presentation

2、contentshouldbeconsideredpreliminary.Paycloseattentiontofiscalyear(FY),calendaryear(CY),oracademicyear(AY)andcut-offdatesondatapresentations;denominatorsareimportanttoo!TalentedstaffatFDAprovidethedataandanalysesforthistalkeachyear.Specialthanksandackn

3、owledgementto:–NaderQassim,NancyMaizel,andRezaKazemi-TabrizinCDER’sOfficeofProgramandStrategicAnalysis–MikeLanthierintheOfficeoftheCommissioner2TopicstobecoveredNewdrugreviewprocessefficiency:ahistoricallookandchangesinPDUFAVINewdrugactivityin2018:appr

4、ovals,workload,internationalcomparisons,andprofilingthe2018classofNMEs/BLAsDevelopmentphaseactivity:INDworkload,thebreakthroughprogram,meetingworkloadandchangesinPDUFAVIAlookaheadto20193•3CDERNewMolecularEntityApprovalRatesbyPDUFACohortProjectionestima

5、tesaccountforactionstodateandelapsedtimetodatefornon-approvalsDataasof11/30/184NewDrugActivityin2018InCY2018sofar*,CDERhasapproved55NMEs,including31orphandrugs–42PriorityReviewedNMEapprovals,morethandoubletherecent5-yearaverageof20priorityapprovalsperye

6、ar–Forthefirsttimeever,themajorityofNMEsapprovedareorphandrugstotreatrarediseases–2018hasauniqueblendoftherapeuticareas,quantityofapprovalsisnotdrivenbyoncologyindicationsasinthepastU.S.continuestoleadtheworldinfirstapprovalofNMEsSeveralNotableApproval

7、s,including:–Epidiolex(Cannabidiol)–CannabinoidApproval–Erleada(Apalutamide)–NovelEndpoint–Lucemyra(LofexidineHydrochloride)-OpioidWithdrawal–TPOXX(tecovirimat)–treatsmallpoxandaddresstheriskofbioterrorism*ThisinformationisaccurateasofNovember30th,2018.I

8、nrareinstances,itmaybenecessaryforFDAtochangeadrug’snewmolecularentity(NME)designationorthestatusofitsapplicationasanewbiologicslicenseapplication(BLA).ThisnoteappliestoallreferencestoNME/OriginalBLAsinthispresentation.5•5