AbbVie files SKYRIZI Crohn’s disease application

• AbbVie submitted a European Medicines Agency application for subcutaneous SKYRIZI induction in Crohn’s disease patients.
• The filing expands potential treatment options beyond the current intravenous induction approach in the EU.
• AbbVie stated the application is supported by Phase 3 AFFIRM study data on efficacy and safety.

AbbVie (NYSE:ABBV) submitted a regulatory application to the European Medicines Agency for subcutaneous SKYRIZI (risankizumab) induction treatment in adults with moderately to severely active Crohn’s disease.

The filing follows positive Phase 3 AFFIRM study results evaluating the efficacy and safety of subcutaneous induction, while SKYRIZI is already approved in the European Union for intravenous induction and subcutaneous maintenance in Crohn’s disease.

AbbVie stated that the application is supported by data from the Phase 3 AFFIRM study, which evaluated subcutaneous SKYRIZI induction in adults with moderately to severely active Crohn’s disease.

If approved, AbbVie stated that patients could have the option to receive either subcutaneous injections or intravenous infusions for induction treatment, followed by subcutaneous maintenance every eight weeks.

SKYRIZI is currently approved in the European Union for several inflammatory conditions, including Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

The application represents AbbVie’s continued expansion of SKYRIZI across inflammatory disease areas, with the company evaluating additional treatment approaches based on clinical trial data.