Cure8 news brief
A subcutaneous induction option could make starting risankizumab easier and less burdensome than IV infusions for many people with Crohn's disease, potentially expanding access and convenience.
Adults with moderately to severely active Crohn's disease, patients considering biologic induction options, clinicians who prescribe biologics, and researchers following IL-23 therapies.
AbbVie has applied to the European Medicines Agency to add a subcutaneous (SC) induction option for SKYRIZI (risankizumab) in adults with moderately to severely active Crohn's disease, citing positive Phase 3 AFFIRM results showing clinical remission and endoscopic response at week 12.
If approved, induction could be started SC or IV, with SC maintenance every eight weeks. This item reports a regulatory submission and summarizes the supporting Phase 3 study as described by AbbVie; it does not provide full study data or independent regulatory review.
It indicates potential increased convenience and choice for patients currently needing IV induction. No new safety signals or detailed numerical results are provided in this summary; clinicians and patients should look for the EMA decision and the full AFFIRM study publication or regulatory briefing for complete efficacy and safety data.
This article summarizes AbbVie's regulatory submission and cites positive Phase 3 AFFIRM results but does not present detailed trial data. Regulatory review by the EMA will determine approval. SKYRIZI is already approved in the EU for Crohn's disease (IV induction) and other immune-mediated conditions.
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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