OMISIRGE (omidubicel-onlv) · Gamida Cell Ltd.
OMISIRGE is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for the treatment of: adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infections.
Details
- Status
- Prescription
- First Approved
- 2023-04-16
- Patent Cliff
- 2030
- Routes
- Intravenous
- Dosage Forms
- For Injection
OMISIRGE Approval History
What OMISIRGE Treats
1 FDA approvalsOriginally approved for its first indication in 2023 .
- Other (1)
Other
(1 approval)- • Approved indication (Apr 2023)
OMISIRGE Boxed Warning
GRAFT VERSUS HOST DISEASE, INFUSION REACTIONS, AUTOIMMUNE CYTOPENIAS, GRAFT FAILURE, and ENGRAFTMENT SYNDROME Graft-vs-Host Disease (GvHD): GvHD may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD [ see Warnings and Precautions (5.1) ]. Infusion reactions: Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentami...
WARNING: GRAFT VERSUS HOST DISEASE, INFUSION REACTIONS, AUTOIMMUNE CYTOPENIAS, GRAFT FAILURE, and ENGRAFTMENT SYNDROME Graft-vs-Host Disease (GvHD): GvHD may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD [ see Warnings and Precautions (5.1) ]. Infusion reactions: Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine material [ see Contraindications (4) , Warnings and Precautions (5.2) ]. Autoimmune cytopenias: Autoimmune cytopenias have occurred following treatment of severe aplastic anemia. Monitor blood counts prior to and after infusion. Manage cytopenias according to local institutional guidelines [see Warnings and Precautions (5.3) ]. Graft failure: Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery [ see Warnings and Precautions (5.4) ]. Engraftment syndrome: Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids [ see Warnings and Precautions (5.6) ]. WARNING: GRAFT VERSUS HOST DISEASE, INFUSION REACTIONS, AUTOIMMUNE CYTOPENIAS, GRAFT FAILURE, and ENGRAFTMENT SYNDROME See full prescribing information for complete boxed warning. Graft-vs-Host Disease (GvHD): GvHD may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD. ( 5.1 ) I nfusion reactions: Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine material. ( 4 , 5.2 ) Autoimmune cytopenias: Autoimmune cytopenias have occurred following treatment of severe aplastic anemia. Monitor blood counts prior to and after infusion. Manage cytopenias according to local institutional guidelines. ( 5.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OMISIRGE FDA Label Details
Indications & Usage
OMISIRGE is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for the treatment of: adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infections. adults and pediatric patients 6 years and older with severe aplastic anemia (SAA) following reduced intensity conditioning. 1.1 Hematologic Malignancies OMISIRGE is indicated for the treatment of adults and pedi...
WARNING: GRAFT VERSUS HOST DISEASE, INFUSION REACTIONS, AUTOIMMUNE CYTOPENIAS, GRAFT FAILURE, and ENGRAFTMENT SYNDROME Graft-vs-Host Disease (GvHD): GvHD may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD [ see Warnings and Precautions (5.1) ]. Infusion reactions...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.