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 firstname.lastname@example.org
(END) Dow Jones Newswires