AbbVie 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. 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.
"Many people continue to struggle with symptoms associated with their ulcerative colitis, such as fatigue, bowel urgency, bloody diarrhea and abdominal pain," said Tom Hudson, senior vice president of research and development, chief scientific officer, AbbVie. "Upadacitinib has the potential to be an important new treatment option for people with ulcerative colitis, who want to address these challenging and disruptive symptoms. We look forward to working with regulatory authorities and hope to bring upadacitinib to people with ulcerative colitis as quickly as possible."
The applications are supported by data from two Phase 3 induction studies and one maintenance study.1-3 In these studies, significantly more patients treated with upadacitinib achieved the primary endpoint of clinical remission (per Adapted Mayo Score) and all secondary endpoints compared to placebo with 45 mg once daily at week 8 for the induction studies, and with 15 mg and 30 mg once daily at 52 weeks for the maintenance study.
The safety results of upadacitinib, including the 45 mg dose as induction therapy, in these studies were generally consistent with the known safety profile of upadacitinib, with no new important safety risks observed.
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