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The U.S. Food and Drug Administration (FDA) has announced it has approved Omisirge (omidubicel-onlv), the hematopoietic stem cell transplant (HSCT) Therapy to treat patients with severe aplastic anemia (SAA).
Omisirge is indicated for adults and pediatric patients 12 years and older with hematologic malignancies and now is approved for adults and patients six years and older with SAA following reduced intensity conditioning and for whom a compatible donor is not available.
"This approval is revolutionary in the therapeutic landscape and fundamentally changes how we approach treatment for SAA, where earlier treatment has potential to alter one's life course," Vinay Prasad, M.D., Chief Medical and Scientific Officer and Director of FDA's Center for Biologics Evaluation Research.
"Severe aplastic anemia is a rare blood disorder that can be fatal, and the FDA remains committed to expanding treatment options for patients with this disease."
SOURCE: U.S. FDA
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