Bristol-Myers, Acceleron: FDA Panel to Review Reblozyl in Myelodysplastic Syndromes
04 December 2019 - 12:35AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 03, 2019 08:20 ET (13:20 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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