FDA approves at-home subcutaneous Skyrizi induction for adults with Crohn's disease

The FDA has approved an at-home subcutaneous induction regimen for AbbVie's Skyrizi in Crohn's disease, offering an alternative to intravenous treatment initiation.

Adults with moderately to severely active Crohn's disease can now begin Skyrizi (risankizumab-rzaa) treatment through an approved subcutaneous induction regimen using an on-body injector, rather than relying exclusively on intravenous induction.

The Phase III AFFIRM study demonstrated superior clinical remission and endoscopic response at week 12 versus placebo, supporting the additional administration option for eligible patients.

Field	Content
Article Type	Approvals
Regulatory Authority	U.S. Food and Drug Administration
Regulatory Decision	Approval of an additional administration regimen
Announcement Date	23 October 2026
Company	AbbVie
Drug Name	Skyrizi
Generic Name	Risankizumab-rzaa
Therapeutic Area	Gastroenterology; inflammatory bowel disease
Approved Indication	Moderately to severely active Crohn's disease in adults
New Administration Option	Subcutaneous induction
Delivery Device	On-body injector
Treatment Location	At-home induction for eligible patients
Previous Induction Route	Intravenous infusion
Supporting Clinical Study	Phase III AFFIRM
Clinical Endpoints	Clinical remission and endoscopic response at week 12
Reported Study Outcome	Superior clinical remission and endoscopic response versus placebo
Numerical Efficacy Results	Not provided in supplied summary
Geography	United States
What Happened	The FDA approved a subcutaneous induction regimen for Skyrizi in adults with moderately to severely active Crohn's disease.
Why It Matters	The new administration option may reduce dependence on infusion-centre visits during treatment initiation and improve convenience for eligible patients.
Clinical Evidence	AFFIRM demonstrated superior clinical remission and endoscopic response at week 12 compared with placebo.
Key Takeaway	Skyrizi now offers an FDA-approved at-home subcutaneous induction option for Crohn's disease, distinct from its established intravenous induction regimen.
What to Watch	Prescribing information, payer coverage, device training, patient uptake, adherence and real-world treatment outcomes.
Primary Source	AbbVie via PR Newswire
Primary Source URL	https://www.prnewswire.com/news-releases/us-fda-approves-subcutaneous-induction-regimen-for-abbvies-skyrizi-risankizumab-rzaa-for-adults-with-moderately-to-severely-active-crohns-disease-302918434.html
Relevant Date	23 October 2026

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