Bristol Myers Squibb (NYSE:BMY)
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1 Month : From Nov 2019 to Dec 2019
By Colin Kellaher
Bristol-Myers Squibb Co. (BMY) and Acceleron Pharma Inc. (XLRN) on Tuesday said a U.S. Food and Drug Administration advisory committee will review the use of the anemia drug Reblozyl in patients with myelodysplastic syndromes.
The companies said the FDA's advisory panel on oncologic drugs will review Bristol-Myers' supplemental biologics license application for Reblozyl at its meeting on Dec. 18.
Celgene Corp., which Bristol-Myers recently acquired, filed with the FDA in April seeking approval of Reblozyl for adults with anemia related to very low to intermediate risk myelodysplastic syndromes with ring sideroblasts who require red blood cell transfusions, as well as adults with anemia related to beta-thalassemia-associated anemia who require red blood cell transfusions.
The agency set a target action date of April 4, 2020, for the indication in patients with myelodysplastic syndromes and recently approved the drug for adults with beta thalassemia under a priority-review designation.
Celgene and Acceleron, a Cambridge, Mass., biopharmaceutical company, are co-developing Reblozyl under a collaboration they formed in 2011.
Write to Colin Kellaher at firstname.lastname@example.org
(END) Dow Jones Newswires
December 03, 2019 08:20 ET (13:20 GMT)
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