FDA Grants Priority Review for Evaluation of Luspatercept in Beta-Thalassemia

June 4, 2019 – Celgene Corporation and Acceleron Pharma Inc. have submitted their Biologics License Application (BLA) for luspatercept to the U.S. Food and Drug Administration (FDA) for review. Luspatercept is an investigational erythroid maturation agent for the treatment of adult patients with beta-thalassemia-associated anemia who require red blood cell transfusions. The FDA has granted Priority Review for the evaluation of luspatercept in beta-thalassemia and has set a Prescription Drug User Fee Act (PDUFA), or target action, date of December 4, 2019. This is the deadline by which the FDA will complete its review of luspatercept for the treatment of beta-thalassemia-associated anemia.

Further information about the luspatercept submission to the FDA is available in the following press release: http://investor.acceleronpharma.com/node/13816

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