仑卡奈单抗(Lecanemab,商品名Leqembi)的NDA审评信息（PMDA）.pdfVIP

ReportontheDeliberationResults

August25,2023

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,LabourandWelfare

BrandNameLeqembiforIntravenousInfusion200mg

LeqembiforIntravenousInfusion500mg

Non-proprietaryNameLecanemab(GeneticalRecombination)(JAN*)

ApplicantEisaiCo.,Ltd.

DateofApplicationJanuary16,2023

ResultsofDeliberation

InitsmeetingheldonAugust21,2023,theFirstCommitteeonNewDrugsconcludedthattheproduct

maybeapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentof

thePharmaceuticalAffairsandFoodSanitationCouncil.

Theproductisclassifiedasabiologicalproduct.There-examinationperiodis8years.Thedrugproduct

anditsdrugsubstancearebothclassifiedaspowerfuldrugs.

ApprovalConditions

1.Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

2.Theapplicantisrequiredtoconductapost-marketinguse-resultssurveycoveringallpatients

treatedwiththeproducttocollectinformationonpatientcharacteristicsuntildatafromaspecified

numberofpatientsareaccrued.Furthermore,theapplicantshouldcollectdataonthesafetyand

efficacyoftheproductearlyandtakenecessaryactiontoensuretheproperuseoftheproduct.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishtranslationofthisJapanesereviewreportisintendedtoserveasreferencematerialmadeavailableforthe

convenienceofusers.Intheeventofanyincon