Gamida Cell, a clinical-stage biopharmaceutical company, announces that it has received positive feedback from the FDA regarding its Type B meeting correspondence for omidubicel. Omidubicel is a prospective lifesaver for patients with blood cancers caused by bone marrow failure. It is the first allogeneic hematopoietic stem cell therapy to receive the FDA’s Breakthrough Therapy designation.
In December of last year, Gamida Cell was asked for the analysis of the complete data of omidubicel through the manufacturing provision. Following the analysis, the FDA and Gamida Cell have reached an agreement that the commercial facility’s data are comparable to those of the product that was manufactured during the Phase 3 study. The company has also agreed to submit a rolling submission of its Biologics License Applications (BLAs) for the approval of omidubicel. This is the first product to receive the FDA’s Breakthrough Therapy designation. The company’s CEO stated that the submission of the BLA will allow Gamida Cell to move closer to bringing new treatments to patients.