Cure8 news brief
An FDA approval of a subcutaneous induction option for risankizumab means adults with moderate-to-severe Crohn's disease can start treatment at home using an on-body injector, which may make starting therapy more convenient and could affect treatment choices.
Adults with Crohn's disease (especially those considering biologic therapy), clinicians who treat IBD, patients on or considering advanced therapies, and IBD researchers tracking new treatment options.
FDA approved a subcutaneous induction regimen for AbbVie's SKYRIZI (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease.
The approval is supported by Phase 3 AFFIRM trial results showing superior clinical remission and endoscopic response at week 12 versus placebo, with particularly strong results in patients without prior advanced therapy failure.
The subcutaneous induction regimen uses a 720 mg on-body injector (OBI) at weeks 0, 2, 4 and 8, with maintenance dosing every eight weeks; an IV induction option (600 mg at weeks 0, 4, 8) remains available.
Safety information in the announcement states the subcutaneous induction safety profile was generally consistent with the established SKYRIZI profile and that no new safety risks were identified. AbbVie also updated U.S. prescribing information language to allow provider clinical judgment on tuberculosis testing across indications.
This is a regulatory approval announcement from AbbVie summarizing trial outcomes and the new route-of-administration option; it is not an independent peer-reviewed publication. Patients should consult their clinicians about whether SKYRIZI and the subcutaneous OBI induction are appropriate for their individual situation.
This is a company press release about an FDA approval supported by the Phase 3 AFFIRM trial. The article summarizes trial results but is not an independent peer-reviewed report; prescribing decisions should be made with a clinician. The announcement also notes an update to labeling regarding TB testing discretion.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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A subcutaneous induction option for SKYRIZI could let people with Crohn’s start and continue treatment with injections instead of beginning with an IV infusion, which may affect convenience, time in clinic, and infusion...
