Posted by Michael Wonder on 06 Jun 2022
Bristol Myers Squibb withdraws supplemental biologics license application for Reblozyl (luspatercept-aamt) for non-transfusion dependent beta thalassaemia
3 June 2022 - Bristol Myers Squibb today announced that the company has withdrawn a supplemental biologics license application for Reblozyl (luspatercept-aamt) for the treatment of anaemia in adults with non-transfusion dependent beta thalassaemia.
The Company could not appropriately address the U.S. Food and Drug Administration’s questions about the benefit-risk profile of Reblozyl in this patient population based on the current dataset from the Phase 2 BEYOND trial.
