Cure8 news brief
A new subcutaneous induction option for risankizumab could make starting IL‑23 therapy more convenient for adults with moderately to severely active Crohn’s disease and expand choices for those who have failed prior therapies.
The change would affect how induction doses are delivered but does not itself mean the EMA has approved the change.
Adults with moderately to severely active Crohn’s disease, patients considering or currently on biologic/IL‑23 therapy, gastroenterology clinicians, and clinical researchers involved in IBD drug development.
This is a company press release describing a formal application to the EMA based on Phase 3 AFFIRM trial results. It does not present full trial data or regulatory decisions.
The submission, if approved, would expand an existing IL‑23 inhibitor option (risankizumab) to include a subcutaneous induction route in addition to the already approved IV induction in the EU.
The AFFIRM study is described as a randomized, placebo‑controlled Phase 3 trial (NCT06063967) with co‑primary endpoints of clinical remission (CDAI <150) and endoscopic response at week 12; 289 patients were randomized (2:1 risankizumab SC:placebo) and about 65% had prior advanced therapy failure.
Full study details and results should be reviewed in the peer‑reviewed publication or regulatory briefing once available. This notice reflects a regulatory submission, not an approval; availability depends on EMA review and labeling decisions.
This is a company press release about a regulatory submission supported by Phase 3 trial data; it is not an EMA approval or a full trial report. For clinical decisions, wait for EMA review, label details, and peer‑reviewed data.
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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