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

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