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
| 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| Provenge | Dendreon | Metastatic prostate cancer | Oct-13 | Withdrawn in 2015 |
| MAXI | Vericel | Cartilage defects in the knee | Jul-13 | Withdrawn in 2014 |
| Glybera | uniQure | Lipoprotein lipase deficiency | Nov-12 | Withdrawn in 2017 |
| Chondrocelect | TiGenix | Cartilage defects | Nov-09 | Withdrawn in 2016 |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. |
To get a quote for the products or to place an order, please email Sales@2BScientific.com.