Celgene and Acceleron Report FDA’s Acceptance of BLA for Luspatercept to Treat Myelodysplastic Syndromes and Beta-Thalassemia

Celgene and Acceleron Report FDA’s Acceptance of BLA for Luspatercept to Treat Myelodysplastic Syndromes and Beta-Thalassemia

Shots:

  • The BLA acceptance follows safety and efficacy data from two P-III MEDALIST and BELIEVE study result assessing Luspatercept vs PBO to treat anemia associated with MDS and beta-thalassemia, with its results presented at ASH 2018  
  • The US FDA has also granted Priority Review to Luspatercept’s BLA for Beta-Thalassemia with PDUFA date of Dec 4,2019 and Apr 4,2020 for Myelodysplastic Syndromes
  • Luspatercept is a novel erythroid maturation agent (EMA) regulating late-stage red blood cell maturation currently evaluated in P-III COMMANDS study for ESA-naïve, lower-risk MDS patients. Additionally, Luspatercept’s MAA is validated in EU with its ongoing review

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