healio.com
Cure8 news brief
FDA approves subcutaneous induction regimen of Skyrizi for Crohn’s disease
Medications
Risankizumab
IL-23 inhibitor
Regulatory Update
Adult patients
Patients On Biologics
Clinicians
Crohn's disease
Why This Matters
This change may make starting Skyrizi easier and more convenient by allowing induction to be done at home rather than IV infusions in a clinic. It expands options among IL‑23 p19 inhibitors for people with moderate to severe Crohn’s disease.
Who Should Pay Attention
Adults with moderately to severely active Crohn’s disease, patients considering biologic therapy or switching regimens, gastroenterologists, infusion centers and IBD care teams.
Study Snapshot
Story typeResearch news
Evidence typeRegulatory update
Source depthFull source text
What To Know
The FDA expanded approval of risankizumab (Skyrizi) to allow a subcutaneous induction regimen for adults with moderately to severely active Crohn’s disease, based on phase 3 AFFIRM trial data.
The approval lets patients begin induction at home using an on-body injector induction pack; previously Skyrizi was approved with IV induction followed by subcutaneous maintenance.
AFFIRM randomized 289 adults (2:1) to a 720 mg subcutaneous regimen at baseline and additional doses at weeks 2, 5 and 8 versus placebo and reported higher rates of clinical remission and endoscopic response at week 12 with risankizumab.
The article references common adverse events reported in the release (eg, upper respiratory infections, headache, injection-site reactions, anemia).
Keep In Mind
The Healio article summarizes a manufacturer press release and phase 3 AFFIRM trial results; the approval is a regulatory update rather than new clinical practice guidance. Individual treatment decisions should be discussed with a clinician. The source cites trial results but is reporting secondary to the release.
Source Details
Review the original publication for the complete reporting, methods, and context.
Regulatory update
Article type assigned from Cure8 classification; confirm details in the original source.
Publicationhealio.com
Indexed viaBing News
Source typeWeb article
PublishedOct 22, 2026, 5:00 PM
Content availableFull source text
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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