Skip to main content
. 2022 Oct 6;16:100099. doi: 10.1016/j.iotech.2022.100099

Table 1.

Marketed ATMP authorized by EMA and FDA

ATMP classification Product Manufacturer Agency
Somatic cell therapy Allogeneic cultured keratinocytes and fibroblasts in bovine collagen Organogenesis FDA
Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low-affinity nerve growth factor receptor (DLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2) MolMed Spa EMA
Darvadstrocel Takeda Pharma EMA
Hematopoietic progenitor cell cord blood Cleveland Cord Blood Center FDA
SSM Cardinal Glennon Children’s Medical Center
Bloodworks
Clinimmune Labs, University of Colorado Cord Blood Bank
Duke University School of Medicine
LifeSouth Community Blood Centers
New York Blood Center
MD Anderson Cord Blood Bank
Sipuleucel-T Dendreon FDA
Alofisel Tigenix EMA
Holoclar Chiesi farmaceutici EMA
Gene therapy Autologous CD34+-enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human hematopoietic stem/progenitor (CD34+) cells GlaxoSmithKline EMA
Imlygic Amgen EMA
Axicabtagene ciloleucel Gilead Sciences EMA
FDA
Talimogene laherparepvec Amgen EMA
FDA
Tisagenlecleucel Novartis EMA
FDA
Luxturna Spark Therapeutics EMA
FDA
Strimvelis Orchard therapeutics EMA
Zynteglo Bluebird bio EMA
Tissue-engineered products Autologous cultured chondrocytes on a porcine collagen membrane-specific marker proteins Chiesi Farmaceutici EMA
Spheroids of human autologous matrix-associated chondrocytes Co.Don AG EMA

ATMP, advanced therapy medicinal products; EMA, European Medicines Agency; FDA, Food and Drug Administration.

HHS Vulnerability Disclosure