FDA Approves At-Home SKYRIZI Induction for Crohn's Disease Backed by AFFIRM
Oct 23, 2026, 5:58 PM EDT1 sourcesAI-analyzed
Why it may matterVerify against the original reporting
Regulatory approval for at-home induction with a strong AFFIRM data set and expanded TB guidance reduces barriers to use, likely boosting SKYRIZI adoption and AbbVie's immunology revenue in the near term, as seen with prior regulatory-driven upticks for biologics.
AI summary
What happened, with direct paths to the underlying reporting
AbbVie received FDA approval for subcutaneous SKYRIZI induction at home with an on-body injector for adults with moderately to severely active Crohn's disease, alongside a TB language update. AFFIRM data show strong Week 12 efficacy, especially in patients without prior advanced therapy, supporting broader uptake and potential near-term revenue growth. The combination of flexible administration and robust clinical results may meaningfully expand SKYRIZI's market opportunity.
FDA approves SC SKYRIZI induction at home for Crohn's disease with OBI.
AFFIRM: Week-12 remission 74% AT-naïve SKYRIZI vs 27% placebo.
Endoscopic response 60% vs 15% in AT-naïve patients.
TB testing language updated; no mandatory TB test before SKYRIZI.
Induction: 720 mg SC weeks 0,2,4,8; maintenance every 8 weeks.
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