Skip to Content

Luspatercept Approval Status

FDA Approved: No (Pending Approval)
Generic name: luspatercept
Company: Celgene Corporation

Luspatercept is a first-in-class erythroid maturation agent (EMA) in development for the treatment of myelodysplastic syndromes (MDS)-associated anemia and beta-thalassemia-associated anemia.

Development Status and FDA Approval Process for luspatercept

DateArticle
Jun  4, 2019Celgene Corporation and Acceleron Pharma Announce U.S. FDA Accepts Luspatercept Biologics License Application in Myelodysplastic Syndromes and Beta-Thalassemia
Apr  5, 2019Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Biologics License Application to U.S. FDA
Dec  2, 2018Celgene Corporation and Acceleron Pharma Announce Results of the Phase 3 MEDALIST Trial Evaluating Luspatercept in Patients with Myelodysplastic Syndromes at the ASH 2018 Plenary Session
Dec  1, 2018Celgene Corporation and Acceleron Pharma Announce Results of the Phase 3 BELIEVE Trial Evaluating Luspatercept in Adult Patients with Beta-Thalassemia at ASH 2018
Jul  9, 2018Celgene and Acceleron Announce Luspatercept Achieved Primary and All Key Secondary Endpoints in Phase III ‘BELIEVE' Study in Adults with Transfusion-Dependent Beta-Thalassemia
Jun 28, 2018Celgene and Acceleron Announce Luspatercept Achieved Primary and Key Secondary Endpoints in Phase III ‘MEDALIST’ Study in Patients with Low-to-Intermediate Risk Myelodysplastic Syndromes
May  6, 2017Luspatercept Phase 2 Data Presented at the 14th International Symposium on Myelodysplastic Syndromes

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide