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Approved ATMPs 

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

EMA Approved ATMPs

Name Developer Indication Approval Date Status
Zynteglo Bluebird bio Feta-thalassemia Jun-19 Conditional Approved
Luxtuma Spark Therapeautics Retinal dystrophy Mar-19 Approved
Yescarta kite pharma B-cell lymphoma Aug-18 Approved
Alofisel TiGenix Perianal fistulas in Crihn's disease Mar-18 Approved
Spherox CO.DON Cartilage defects in the knee May-17 Approved
Zalmoxis MolMed Stem cell transplantation for blood cancer Jun-16 Approved
Strimvelis GSK ADA-SCID Apr-16 Approved
lmlygic Amgen Melanoma Oct-15 Approved
Holoclar Chiesi Limbal stem cell deficiency in the eyes Mar-15 Approved
Provenge Dendreon Metastatic prostate cancer Oct-13 Withdrawn in 2015
MAXI Vericel Cartilage defects in the knee Jul-13 Withdrawn in 2014
Glybera uniQure Lipoprotein lipase deficiency Nov-12 Withdrawn in 2017
Chondrocelect TiGenix Cartilage defects Nov-09 Withdrawn in 2016

FDA Approved ATMPs

Proper Name Tradename Manufacturer
Idecabtagene vicleucel ABECMA Celgene Corporation, a Bristol-Myers Squibb Company
HPC, Cord Blood ALLOCORD SSM Cardinal Glennon Children's Medical Center
lisocabtagene maraleucel BREYANZI Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
HPC, Cord Blood Clevecord Cleveland Cord Blood Center
HPC, Cord Blood Ducord Duke University School of Medicine
Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen GINTUIT Organogenesis Incorporated
HEMACORD (HPC, Cord Blood) Hemacord New York Blood Center, Inc
HPC, Cord Blood None Clinimmune Labs, University of Colorado Cord Blood Bank
HPC, Cord Blood None MD Anderson Cord Blood Bank
HPC, Cord Blood None LifeSouth Community Blood Centers, Inc.
HPC, Cord Blood None Bloodworks
Talimogene laherparepvec None Amgen Inc.
Laviv Azficel-T Fibrocell Technologies, Inc.
Voretigene neparvovec-rzyl LUXTURNA Spark Therapeutics, Inc.
Autologous Cultured Chondrocytes on a Porcine Collagen Membrane MACI Vericel Corporation
Sipuleucel-T PROVENGE Dendreon Corporation
Allogeneic processed thymus tissue–agdc RETHYMIC Enzyvant Therapeutics GmbH
Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen- dsat STRATAGRAFT Stratatech Corporation
Brexucabtagene autoleucel TECARTUS Kite Pharma, Inc
Axicabtagene ciloleucel YESCARTA Kite Pharma Inc.
Onasemnogene abeparvovec-xioi ZOLGENSMA Novartis Gene Therapies, Inc.

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