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Cure8 news brief
Skyrizi Gains FDA Approval for Subcutaneous Induction in Crohn Disease
Medications
Risankizumab
IL-23 inhibitor
Regulatory Update
Adult patients
Patients On Biologics
Clinicians
Researchers
Why This Matters
A new FDA-approved subcutaneous induction option lets adults with moderately to severely active Crohn disease start risankizumab at home via an on-body injector instead of beginning with an IV infusion. That can make starting this IL-23 inhibitor more convenient for patients and clinics.
Who Should Pay Attention
Adults with Crohn disease, patients considering or currently on biologic therapy, gastroenterologists, and IBD care teams.
Study Snapshot
Story typeResearch news
Evidence typeRegulatory update
Source depthFull source text
What To Know
The FDA has approved a subcutaneous (SC) induction regimen for Skyrizi (risankizumab-rzaa) as an option to start treatment for adults with moderately to severely active Crohn disease.
The SC option uses an on-body injector (OBI) induction pack (two 360 mg cartridges plus OBIs) given at weeks 0, 2, 4, and 8; maintenance is then continued by SC injection (180 mg or 360 mg) starting at week 12 and every 8 weeks.
The approval was supported by the phase 3 AFFIRM trial (NCT06063967), which reported higher rates of clinical remission and endoscopic response at week 12 for risankizumab versus placebo. Patients may still elect to begin induction with a 600 mg IV infusion (weeks 0, 4, 8) instead of the SC OBI regimen.
The prescribing information was also updated to advise clinicians to consider tuberculosis assessment before starting treatment, consistent with other biologics. This is a regulatory approval update describing a new route/schedule option for an already approved drug and does not provide individualized treatment advice.
Check full prescribing information and discuss with your clinician to see whether this option fits your situation.
Keep In Mind
This article summarizes an FDA regulatory decision and trial abstract/summaries provided by the sponsor and FDA documents. The approval reflects trial results reported for the phase 3 AFFIRM study; consult the full prescribing information for dosing details, contraindications, and safety monitoring (including TB assessment).
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.
Publicationempr.com
Indexed viaBing News
Source typeWeb article
PublishedOct 26, 2026, 7:05 AM
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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