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AbbVie Inc (NYSE: ABBV) has submitted applications seeking approval for upadacitinib (15 mg and 30 mg (maintenance dose) and 45 mg (induction dose)) for active ulcerative colitis to FDA and the European Medicines Agency (EMA).
The applications cover patients who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
The applications are supported by data from two Phase 3 induction studies and one maintenance study.
In these studies, significantly more patients treated with upadacitinib achieved the primary endpoint of clinical remission and all secondary endpoints compared to placebo.
Related content: Benzinga's Full FDA Calendar.
Price Action: ABBV shares are down 0.21% at $107.55 during the market session on the last check Thursday.
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