US biopharmaceutical company AbbVie (NYSE: ABBV) announced on Thursday that it has applied to the European Medicines Agency for approval of subcutaneous induction dosing of SKYRIZI (risankizumab) for adults with moderately to severely active Crohn's disease.

Risankizumab, an interleukin-23 inhibitor targeting the p19 subunit, is already authorised in the European Union for intravenous induction, and is already approved in both the EU and US for plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.

The submission is supported by positive Phase 3 data from the AFFIRM study, which assessed the efficacy and safety of subcutaneous risankizumab in patients with and without prior advanced therapy failure. AFFIRM randomised 289 adults in a 2:1 ratio to risankizumab or placebo, with co-primary endpoints of CDAI clinical remission and endoscopic response at week 12.

The trial comprises a 12-week placebo-controlled induction period, a 12-week extended period with blinded or open-label treatment, and a 52-week open-label maintenance phase. 65% of participants had previously failed advanced therapies, and baseline characteristics were generally balanced across study arms.

Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract that can lead to progressive damage, complications and surgery, with symptoms that impose physical, emotional and economic burdens. If authorised, Crohn's disease patients would be able to receive induction via either subcutaneous injection or intravenous infusion, followed by subcutaneous maintenance every eight weeks.