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Approved ATMPs

List of current Advanced Therapy Medicinal Products (ATMPs) approved by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA)

EMA Approved ATMPs

NameDeveloperIndicationApproval DateStatus
ZyntegloBluebird bioFeta-thalassemiaJun-19Conditional Approved
LuxtumaSpark TherapeauticsRetinal dystrophyMar-19Approved
Yescartakite pharmaB-cell lymphomaAug-18Approved
AlofiselTiGenixPerianal fistulas in Crihn's diseaseMar-18Approved
SpheroxCO.DONCartilage defects in the kneeMay-17Approved
ZalmoxisMolMedStem cell transplantation for blood cancerJun-16Approved
HoloclarChiesiLimbal stem cell deficiency in the eyesMar-15Approved
ProvengeDendreonMetastatic prostate cancerOct-13Withdrawn in 2015
MAXIVericelCartilage defects in the kneeJul-13Withdrawn in 2014
GlyberauniQureLipoprotein lipase deficiencyNov-12Withdrawn in 2017
ChondrocelectTiGenixCartilage defectsNov-09Withdrawn in 2016

FDA Approved ATMPs

Proper NameTradenameManufacturer
Idecabtagene vicleucelABECMACelgene Corporation, a Bristol-Myers Squibb Company
HPC, Cord BloodALLOCORDSSM Cardinal Glennon Children's Medical Center
lisocabtagene maraleucelBREYANZIJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
HPC, Cord BloodClevecordCleveland Cord Blood Center
HPC, Cord BloodDucordDuke University School of Medicine
Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine CollagenGINTUITOrganogenesis Incorporated
HEMACORD (HPC, Cord Blood)HemacordNew York Blood Center, Inc
HPC, Cord BloodNoneClinimmune Labs, University of Colorado Cord Blood Bank
HPC, Cord BloodNoneMD Anderson Cord Blood Bank
HPC, Cord BloodNoneLifeSouth Community Blood Centers, Inc.
HPC, Cord BloodNoneBloodworks
Talimogene laherparepvecNoneAmgen Inc.
LavivAzficel-TFibrocell Technologies, Inc.
Voretigene neparvovec-rzylLUXTURNASpark Therapeutics, Inc.
Autologous Cultured Chondrocytes on a Porcine Collagen MembraneMACIVericel Corporation
Sipuleucel-TPROVENGEDendreon Corporation
Allogeneic processed thymus tissue–agdcRETHYMICEnzyvant Therapeutics GmbH
Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen- dsatSTRATAGRAFTStratatech Corporation
Brexucabtagene autoleucelTECARTUSKite Pharma, Inc
Axicabtagene ciloleucelYESCARTAKite Pharma Inc.
Onasemnogene abeparvovec-xioiZOLGENSMANovartis Gene Therapies, Inc.

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