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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