Bristol Myers Squibb Gets FDA Acceptance of sBLA for Reblozyl
03 December 2021 - 11:46PM
Dow Jones News
By Chris Wack
Bristol Myers Squibb said the U.S. Food and Drug Administration
has accepted for priority review its supplemental Biologics License
Application for Reblozyl luspatercept-aamt for the treatment of
anemia in adults with non-transfusion dependent beta
thalassemia.
The company said the FDA has set a Prescription Drug User Fee
Act goal date of March 27, 2022.
Bristol Myers also said the European Medicines Agency has
validated the Type II variation for Reblozyl in NTD beta
thalassemia. Reblozyl is being co-developed and co-commercialized
with Merck & Co. Inc. following Merck's recent acquisition of
Acceleron Pharma Inc.
These applications were based on safety and efficacy results
from a Phase 2 study evaluating Reblozyl plus best supportive care
in patients with NTD beta thalassemia.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
December 03, 2021 07:31 ET (12:31 GMT)
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