Celgene and Acceleron Pharma Submit Biologics License Application (BLA) to the US FDA for Luspatercept

Shots:

• The BLA submission is based on P-III MEDALIST & BELIEVE studies. The P-III MEDALIST study involves assessing of luspatercept (1.0 mg/kg) vs PBO in 229 patients with low to intermediate risk myelodysplastic syndromes (MDS)-associated anemia + RBC transfusion aged ~71yrs across 11 countries
• The P-III BELIEVE study involves assessing of luspatercept (1.0 mg/kg) + BSC vs PBO + BSC in 336 patients with beta-thalassemia + regular RBC transfusions aged ~30 yrs. across 15 countries
• Luspatercept (SC) is an erythroid maturation agent (EMA) administered every 21 days regulating red blood cell maturation with expected MAA submission to EMA in Q2’19, and is evaluated in P-III/P-II COMMANDS/BEYOND studies in lower-risk MDS & non-transfusion-dependent beta-thalassemia patients respectively

Click here to read full press release/ article | Ref: Celgene | Image: The Street