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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.

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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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