By Chris Wack
Gamida Cell Ltd. said that after getting a positive Type B meeting correspondence from the U.S. Food and Drug Administration on Tuesday, it plans to initiate a rolling Biologics License Application submission for omidubicel, a treatment for patients with blood cancers in need of stem cell transplant.
The company previously disclosed that the FDA requested a revised analysis of the manufacturing data generated at Gamida Cell's wholly owned commercial manufacturing facility to demonstrate the analytical comparability to the Lonza clinical manufacturing site that produced omidubicel for the Phase 3 study.
Gamida Cell and the FDA have now reached alignment that analytical comparability has been established between the commercial manufacturing facility and the product that was manufactured for the Phase 3 study.
Based on this demonstration of comparability, along with the positive clinical results of the Phase 3 study, the FDA has agreed that the initiation of a rolling BLA submission is appropriate. Additional clinical data won't be required to initiate the BLA submission.
Gamida Cell said it plans to complete the full BLA submission in the first half of this year.
Gamida Cell shares were up 12% to $2.49 in premarket trading.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires