FDA accepts for priority review Bristol Myers's Reblozyl application in beta thalassemia

Bristol Myers Squibb (NYSE:BMY) announces that the FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for Reblozyl (luspatercept-aamt), for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia.
The FDA has set a PDUFA goal date of March 27, 2022.
These applications were based on safety and efficacy results from the Phase 2 BEYOND study evaluating Reblozyl plus best supportive care in patients with NTD beta thalassemia.
Reblozyl is being co-developed with Merck, following the recent acquisition of Acceleron Pharma.
In June 2021, BMY reported promising Reblozyl data in adults with NTD beta thalassemia.