Posted by Michael Wonder on 04 Dec 2021
U.S. Food and Drug Administration accepts for priority review supplemental biologics license application for Reblozyl (luspatercept-aamt) in adults with non-transfusion dependent beta thalassaemia
3 December 2021 - Submission based on results from Phase 2 BEYOND study of Reblozyl plus best supportive care in adults with NTD beta thalassaemia.
Bristol Myers Squibb today announced that the U.S. FDA has accepted for priority review the supplemental Biologics License Application for Reblozyl (luspatercept-aamt), a first in class erythroid maturation agent, for the treatment of anaemia in adults with non-transfusion dependent beta thalassaemia.
The FDA has set a Prescription Drug User Fee Act goal date of 27 March 2022.
In addition, the European Medicines Agency has validated the Type II variation for Reblozyl in non-transfusion dependent beta thalassaemia.
