AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

PRESS RELEASE Corporate Announcements

11/10/2021

AbbVie

NORTH CHICAGO, Ill., Sept. 16, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg (maintenance dose) and 45 mg (induction dose)) for the treatment of adults with moderately to severely active ulcerative colitis to the U.S. Food and Drug Administration (FDA), and to the European Medicines Agency (EMA) for the treatment of adults with moderately to severely active ulcerative colitis, who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

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