BRUSSELS/FRANKFURT/PARIS (dpa-AFX) - AbbVie (ABBV) announced Wednesday that the European Commission approved SKYRIZI (risankizumab) for the treatment of moderate to severe active Crohn's disease.
It is the first specific interleukin-23 or IL-23 inhibitor in the European Union for the treatment of adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.
Crohn's disease is a chronic, systemic inflammatory disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea, abdominal pain and can require urgent medical care.
The EU approval for SKYRIZI in Crohn's disease is supported by results from the global Phase 3 program, which included three studies: ADVANCE induction, MOTIVATE induction and FORTIFY maintenance.
The three trials are multicenter, randomized, double-blind, placebo-controlled studies and include assessments of efficacy, safety and tolerability of SKYRIZI.
In the trials, a significantly higher proportion of patients on SKYRIZI achieved clinical remission, endoscopic response, mucosal healing and endoscopic remission at week 12 in induction studies compared to placebo.
Further, a significantly higher proportion of patients achieved clinical remission and endoscopic response at week 52 with SKYRIZI maintenance.
SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
SKYRIZI is also approved in the EU for the treatment of adults with psoriasis and psoriatic arthritis.
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