FDA Accepts Gamida's BLA For Omidubicel With Priority Review

(RTTNews) - Gamida Cell Ltd. (GMDA), on Monday, announced that the U.S. Food and Drug Administration or FDA has accepted for filing the company's Biologics License Application or BLA for omidubicel for the treatment of patients with blood cancers in need of an allogenic hematopoietic stem cell transplant.

Omidubicel is a first-in-class, advanced NAM-enabled stem cell therapy candidate with breakthrough and orphan drug designations, the company said.

The FDA granted Priority Review for the BLA and has set a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2023. Upon FDA approval, omidubicel will be manufactured at the Gamida Cell owned manufacturing facility in Israel.

The omidubicel BLA is supported by the statistically significant results from Gamida Cell's pivotal Phase 3 study, the results of which were published in Blood, the official journal of the American Society of Hematology.

Further, the company stated that the study's primary endpoint results demonstrated a median time to neutrophil engraftment of 12 days for patients randomized to omidubicel compared to 22 days for the comparator group. The secondary endpoints of this Phase 3 study were all achieved and were statistically significant. Omidubicel was generally well tolerated in the Phase 3 study.

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