Ayrmid Ltd. receives FDA acceptance and priority review for omidubicel in Severe Aplastic Anaemia
Tuesday, August 26, 2025
Ayrmid Ltd., the parent company of Gamida Cell Inc., has announced that the US Food and Drug Administration (FDA) has accepted its supplementary Biologics License Application (sBLA) for omidubicel in the treatment of Severe Aplastic Anaemia (SAA). The application has been granted priority review, with a Prescription Drug User Fee Act (PDUFA) target action date set for 10 December 2025.
The submission is supported by data from an investigator-led study at the National Heart, Lung, and Blood Institute of the National Institutes of Health.
SAA is a rare and life-threatening blood disorder caused by bone marrow failure and low circulating blood cells. While haematopoietic stem cell transplantation can provide a cure, many patients lack a suitable matched sibling donor, leaving a significant unmet medical need.
If approved, omidubicel would represent a new treatment option for patients with SAA and expand Ayrmid’s commercial haematology portfolio, which currently includes Omisirge® for haematologic malignancies and APHEXDA® for autologous transplantation.
Source: businesswire.com
