Shots:

• The submission is based on the P-II (BEYOND) study to evaluate the efficacy & safety of Reblozyl + BSC vs PBO in a ratio (2:1) in 145 adults with NTD beta-thalassemia. Reblozyl is being co-developed & co-commercialized with Merck, following Merck’s acquisition of Acceleron
• The 1EPs of study is the proportion of patients with mean change in hemoglobin values from baseline ≥1.0 g/dL @12wks. from 13wks. to 24wks. of treatment in absence of transfusions. The 2EPs include a change in NTDT-PRO tiredness & weakness domain score & baseline Hb
• Reblozyl is an erythroid maturation agent for the treatment of anemia in adults with NTD beta-thalassemia & an anticipated PDUFA date is Mar 27, 2022

Ref: Businesswire | Image: BMS