Bristol-Myers Squibb: Deucravacitinib Applications Advance in U.S., Europe
November 29 2021 - 7:59AM
Dow Jones News
By Colin Kellaher
Bristol-Myers Squibb Co. on Monday reported regulatory advances
in the U.S. and Europe for deucravacitinib, its potential rival to
Amgen Inc.'s blockbuster Otezla, in moderate to severe plaque
psoriasis.
The New York biopharmaceutical company said the U.S. Food and
Drug Administration accepted its new-drug application for
deucravacitinib for adults with the autoimmune disorder and set a
target action date of Sept. 10, 2022.
In addition, Bristol-Myers said the European Medicines Agency
validated its marketing authorization application, confirming the
submission is complete and beginning the centralized review
process.
The applications are supported by results from a Phase 3 program
that showed superior efficacy of deucravacitinib over Otezla and
placebo in adults with moderate to severe plaque psoriasis,
Bristol-Myers said.
Amgen bought Otezla from Celgene Corp. for $13.4 billion in a
2019 deal that paved the way for regulatory approval Celgene's $74
billion acquisition by Bristol-Myers.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 29, 2021 07:44 ET (12:44 GMT)
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