CELG Celgene Corporation

By Colin Kellaher

Celgene Corp. (CELG) on Tuesday said the U.S. Food and Drug Administration accepted its biologics-license application for luspatercept, an anemia drug it is developing with Acceleron Pharma Inc. (XLRN), and granted priority review to one of the indications covered by the filing.

The Summit, N.J., biopharmaceutical company said the FDA set a priority target action date of Dec. 4 for the treatment of adults with very low to intermediate-risk myelodysplastic syndromes-associated anemia who have ring sideroblasts and require red-blood-cell transfusions.

Celgene said the FDA set a standard-review target action date of April 4, 2020, for the treatment of adults with beta-thalassemia-associated anemia who require red-blood-cell transfusions.

The company also said its marketing authorization application in the European Union has been successfully validated, and the EU review is now underway.

Celgene and Acceleron, based in Cambridge, Mass., formed their development and commercialization collaboration in 2011.

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

(END) Dow Jones Newswires

June 04, 2019 08:09 ET (12:09 GMT)

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