Shots:

• The approval is based on P-III BELIEVE study assessing Reblozyl (1.0 mg/kg- SC) + BSC vs PBO + BSC in 336 patients in a ratio (2:1) requiring RBC transfusions (6-20 RBC units/ 24wks. with no transfusion-free period greater than 35 days during that period) due to beta-thalassemia
• The P-III BELIEVE study results: improvement in 1EPs & 2EPs i.e- @13–24 wks. ≥33% reduction in RBC transfusion burden (21.4% vs 4.5%); @37-48wks. transfusion burden reduction of at least 33% (19.6% vs 3.6%); @ 13-24 wks. & 37-48 wks. transfusion burden reduction of ≥50% (7.6% & 10.3% vs 1.8% & 0.9%)
• Reblozyl is a first-in-class erythroid maturation agent- jointly developed by Celgene and Acceleron and has received FDA’s PR designation with its anticipated availability in 1wk. following the FDA approval in the US

Click here- ­ Click here to­ read full press release/ article | Ref: FDA- PRNewswire  | Image: The Wall Street Journal