European Commission approves AbbVie’s Rinvoq for the treatment of moderate to severe ulcerative colitis

(RTTNews) – The European Commission has approved Rinvoq (upadacitinib 45mg, 15mg and 30mg) for the treatment of adult patients with moderate to severe active ulcerative colitis who had an inadequate response, lost response or were intolerant to conventional treatment or a biological agent, AbbVie (ABBV) said in a statement on Tuesday.

Approval is based on the results of three Phase 3 studies. In clinical trials, Rinvoq achieved the primary endpoint of clinical remission (according to the adapted Mayo score) at week 8 in induction studies and at week 52 in the maintenance study, as well as all secondary endpoints, including clinical response and mucosal healing.

The approval represents Rinvoq’s fifth therapeutic indication in the European Union.

Rinvoq has already been approved in the European Union for the treatment of moderate to severe active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis and moderate to severe atopic dermatitis.

Rinvoq is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.

Ulcerative colitis is an immune-mediated chronic inflammatory bowel disease that can lead to significant burden and often disability in patients.

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