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AbbVie:CHMP Recommends European Commission Approval Of Upadacitinib For Ulcerative Colitis Treatment

The European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP adopted a positive opinion recommending the approval of upadacitinib (RINVOQ, 45 mg [induction dose] and 15 mg and 30 mg [maintenance dose]) for the treatment of adult patients 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, AbbVie (ABBV) said in a statement on Monday.

If approved by the European Commission, this would be upadacitinib's fifth therapeutic indication in the European Union. The European Commission decision is anticipated in the third quarter of 2022.

Ulcerative colitis is the chronic inflammation of the large intestine, usually beginning in the rectum and lower colon, but may also spread continuously to involve the entire colon, which could lead to a significant burden and disability for patients.

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