Dec. 8 (UPI) -- The U.S. Food and Drug Administration on Monday announced the approval of the first hematopoietic stem cell transplant therapy to treat patients with rare but severe aplastic anemia.
Omidubicel-onlv is allowed for patients 6 and older after reduced intensity conditioning, the FDA said in a news release.
Gamida Cell Inc., a leader in cell therapy innovation with headquarters in Boston and Israel, was the applicant. Ayrmid Ltd. is the British-headquartered parent company.
Omisirge production will take place in RoslinCT's manufacturing facility in Hopkinton, Mass., beginning in two years, Ayrmid said.
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