Priority Review for Gamida sBLA for Omidubicel

FDA has accepted for priority review a Gamida Cell supplemental BLA for omidubicel and its use in severe aplastic anemia, a rare and often life-threatening condition in which the bone marrow fails to produce sufficient blood cells. Hematopoietic stem cell transplants can be curative, but many patients lack a matched sibling donor, leaving them with limited treatment options, the company says.

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, according to the company. The agency has set a 12/10 user fee review action target date.

Omidubicel is described by the company as a nicotinamide-modified, allogeneic hematopoietic progenitor cell therapy derived from umbilical cord blood. The therapy received FDA approval in 2023 for patients with blood cancers undergoing stem cell transplant.