Reduction of transfusion burden represents an important step forward for patients with this rare and debilitating blood disease,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “For decades, the management of beta-thalassemia in adults has been limited to transfusions and iron chelation. Adverse events observed in the study were generally consistent with previously reported data. In addition to achieving the primary endpoint of the study, luspatercept also met all key secondary endpoints of demonstrating statistically significant improvements in RBC transfusion burden from baseline of at least a 33 percent reduction during the period from week 37 to week 48, at least a 50 percent reduction during the period from week 13 to week 24, at least a 50 percent reduction during the period from week 37 to week 48, and a mean change in transfusion burden from week 13 to week 24.
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