WASHINGTON (dpa-AFX) - AbbVie (ABBV) announced that the U.S. Food and Drug Administration approved a subcutaneous induction regimen for SKYRIZI (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease, providing patients with a new option to begin treatment at home.
The approval is supported by positive results from the Phase 3 AFFIRM trial, which evaluated the efficacy and safety of subcutaneous SKYRIZI versus placebo in patients with moderately to severely active Crohn's disease. The study met its co-primary endpoints, with SKYRIZI demonstrating superiority in achieving both clinical remission and endoscopic response at Week 12.
With the newly approved subcutaneous induction regimen, patients can start SKYRIZI treatment at home using an on-body injector (OBI) induction pack and continue maintenance treatment with an OBI every eight weeks. The SC induction dosing schedule consists of 720 mg administered at Weeks 0, 2, 4 and 8. Patients may also choose the previously approved intravenous induction regimen of 600 mg at Weeks 0, 4 and 8 before transitioning to maintenance dosing beginning at Week 12.
AbbVie said the approval expands flexibility for patients and healthcare providers by offering a fully subcutaneous treatment pathway from induction through maintenance.
In addition, the FDA approved an update to SKYRIZI's prescribing information across all approved indications. The revised warning and precautions language advises healthcare providers to consider tuberculosis (TB) evaluation before treatment initiation based on clinical judgment. The update removes any requirement for mandatory TB testing prior to starting SKYRIZI, giving physicians greater flexibility in patient assessment while maintaining appropriate safety oversight.
ABBV closed Friday's regular trading at $285.64 up $0.45 or 0.16%.
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