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DewDiligence

04/03/20 8:07 PM

#230431 RE: DewDiligence #226753

BMY/XLRN—FDA approves Reblozyl for correction of anemia in certain MDS patients:

https://finance.yahoo.com/news/u-food-drug-administration-fda-210800372.html

Bristol Myers Squibb and Acceleron Pharma…today announced the U.S. Food and Drug Administration (FDA) has approved Reblozyl (luspatercept-aamt), the first and only erythroid maturation agent (EMA), for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T). Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.1

This second FDA-approved indication for Reblozyl looks like a rather limited market. The FDA approved Reblozyl for beta thalassemia in Nov 2019 (#msg-152178518).

Reblozyl came to BMY from CELG, but it is not a constituent of the Celgene CVR (BMY-R).