Omisirge FDA Approval History
Last updated by Judith Stewart, BPharm on May 1, 2023.
FDA Approved: Yes (First approved April 17, 2023)
Brand name: Omisirge
Generic name: omidubicel-onlv
Dosage form: Suspension for Infusion
Company: Gamida Cell Ltd.
Treatment for: Stem Cell Therapy
Omisirge (omidubicel-onlv) is a nicotinamide (NAM) modified allogeneic hematopoietic progenitor cell therapy for use in patients with hematologic malignancies to reduce risk of infection following stem cell transplantation.
- Omisirge is indicated for use in 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 infection.
- Hematologic malignancies (blood cancers) are caused by abnormal cell growth in the bone marrow, where stem cells form into different types of blood cells. a A common treatment for blood cancers is stem cell transplantation from umbilical cord blood. In preparation for transplantation, patients undergo myeloablative conditioning which is a course of treatment (such as radiation or chemotherapy) to remove a patient's own stem cells. It can cause weakening of the immune system, increasing the risk of severe and potentially fatal infections.
- Omisirge is composed of human allogeneic (donor) stem cells from umbilical cord blood that are processed and cultured with NAM to enhance the number and functionality of the targeted cells. In clinical trials, Omisirge showed faster neutrophil recovery and reduced bacterial and fungal infections as compared to standard cord blood.
- Omisirge is administered via a single intravenous infusion. A patient-specific single dose consists of a Cultured Fraction (CF) and a Non-cultured Fraction (NF). The CF bag is administered first, followed by the NF bag within 1 hour after completion of the CF infusion. Patients receive premedication with an antihistamine, hydrocortisone, and acetaminophen approximately 30 to 60 minutes prior to receiving Omisirge.
- The Omisirge product label carries a Boxed Warning for infusion reactions, graft versus host disease (GvHD), engraftment syndrome, and graft failure. Warnings and precautions associated with Omisirge include malignancies of donor origin, transmission of serious infections, and transmission of rare genetic diseases.
- The most common adverse reactions (incidence > 20%) include infections, GvHD, and infusion reactions.
Development timeline for Omisirge
Further information
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