2012 FDA drug approvals.doc
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2012 FDA drug approvals.doc

2012FDAdrugapprovals.doc

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M&Afirepowershiftsp91Druggingtheepigenomep92SingleEuropeanpatentedgescloserp94MikeYeadondiscussesstartingacompanyafterpharmadownsizingp96Marketforsmokingcessationtherapiesp97Asher?MullardTheUSFoodandDrugAdministration(FDA)’sCenterforDrugEvaluationandResearch(CDER)approved39newdrugslastyear,markinga15?yearhigh.Thisisthemostgreenlightssince1997,andaround33%higherthantheaverageoverthepasttwodecades(30approvalsperyear;seeFIG.1).JohnJenkins,DirectoroftheOfficeofNewDrugsattheCDER,addsthatothermetricssuggesttheapprovalprocessisincomparativelyrudehealth.Forone,thefirst?cycleapprovalrate(thatis,drugsthatwereapprovedafteronlytheirfirstreview)wasaround80%forproductsactedonin2012.“That’shigherthaneverbefore.”Thisrateessentiallymatchesthehistoricoverallapprovalrate,whichincludesdrugsthatgothroughmultipleroundsof?review.Thefactorsthatunderliethehighfirst?cycleapprovalrate,speculatesJenkins,couldincludeincreasedinteractionsbetweenregulatorsandcompaniesduringthedevelopmentofdrugs,betterqualityapplications,fewersubmissionsof‘me?too’candidates(20ofthedrugsapprovedbytheFDAlastyearwerefirst?in?classagents)andclearerbenefit–riskbalances.“Wesawahighrateoffirst?cycleapprovalsin2011aswell,”addsJenkins.“Itisaninterestingphenomenon:wehaven’tchangedthestandardsofapproval,soIwouldhavetothinktheprocessisefficientandrunningwell.”Ifthefirst?cycleapprovalratestayshigh,preliminarydataonthenewmolecularentity(NME)andbiologicslicenseapplication(BLA)submissionsin2012suggestthat2013couldbeyetanothergoodyear.TheFDAreceived43NMEandnewBLAapplicationsin2012,roughlyinlinewiththe41thatitfiledin2011.Jenkinscautionsagainstusingsubmissionvolumetopredict2013approvals,giventhevariablesinherentindrugreviewandthelagtimebetweenfilingandactiondates,butisneverthelessencouragedthatsubmissionsareat“thehighestnumberswe’veseeninthepasthalfadecadeorso”.TheongoingdebatearoundtheUnitedS