By Colin Kellaher

Celgene Corp. (CELG) on Tuesday said it expects to file a biologics-license application with the U.S. Food and Drug Administration in April for luspatercept, which it is jointly developing with fellow biopharmaceutical company Acceleron Pharma Inc. (XLRN).

The BLA will cover adults with anemia related to very low to intermediate myelodysplastic syndromes with ring sideroblasts who require red blood cell transfusions, and adults with anemia related to beta-thalassemia who require regular red blood cell transfusions.

Celgene, based in Summit, N.J., and Acceleron, based in Cambridge, Mass., in December said a phase 3 study showed luspatercept resulted in statistically significant increased red blood cell transfusion independence compared to placebo, adding that they planned to make regulatory submissions in the U.S. and Europe in the first half of 2019.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

February 26, 2019 08:39 ET (13:39 GMT)

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