Celgene’s Reblozyl (luspatercept–aamt) Receives FDA’s Approval as the First Therapy to Treat Patients with Rare Blood Disorder

Celgene’s Reblozyl (luspatercept–aamt) Receives FDA’s Approval as the First Therapy to Treat Patients with Rare Blood Disorder

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