Pharmaceutical research & development company AbbVie (NYSE:ABBV) on Friday announced European Commission approval for SKYRIZI (risankizumab) for the treatment of moderately to severely active ulcerative colitis (UC).
SKYRIZI is targeted at patients who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.
This marks its fourth approved indication in the European Union.
UC affects an estimated 5 million people globally. SKYRIZI demonstrated efficacy in achieving clinical remission and key secondary endpoints in Phase 3 trials.
Notably, the drug showed positive results in mucosal healing, particularly among patients without prior biologic therapy or JAK inhibitor failure. SKYRIZI's safety profile was consistent with previous studies.
AbbVie is leading SKYRIZI's global development and commercialisation under a collaboration with Boehringer Ingelheim.
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