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CELG :FDA Accepts Luspatercept BLA In Myelodysplastic Syndromes,Beta-Thalassemia

Celgene Corp. (CELG) and Acceleron Pharma Inc. (XLRN) said Tuesday that the U.S. Food and Drug Administration accepted Celgene's Biologics License Application or BLA for luspatercept, an investigational erythroid maturation agent, for the treatment of adult patients with very low to intermediate-risk myelodysplastic syndromes or MDS-associated anemia who have ring sideroblasts and require red blood cell or RBC transfusions, and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions.

The FDA granted Priority Review to the BLA to evaluate the beta-thalassemia indication and set a target action date of December 4, 2019. The FDA has also set target action date of April 4, 2020 to evaluate the MDS indication.

Celgene believes that luspatercept can play a critical role in treating the anemia associated with these serious blood diseases.

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