AbbVie (NYSE: ABBV) wins FDA approval for Skyrizi injections from the start of Crohn's treatment
A subcutaneous induction option extends the product's convenience beyond maintenance therapy.
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The FDA has approved a subcutaneous induction regimen for AbbVie's Skyrizi in adults with moderately to severely active Crohn's disease. Patients can now begin treatment using an on-body injector at home and subsequently continue injectable maintenance therapy.
The decision is supported by the Phase 3 AFFIRM trial. At week 12, clinical remission occurred in 56% of patients receiving subcutaneous Skyrizi, compared with 30% receiving placebo. Endoscopic response was 43% versus 15%.
These are results for the overall study population. Higher response figures in patients without prior advanced-therapy failure should not be substituted for the overall findings.
The commercial significance is practical: the new regimen could reduce the logistical burden of starting treatment and give clinicians another administration option. It does not establish superiority over other Crohn's medicines. Uptake will depend on prescribing preferences, insurance arrangements and whether the more flexible initiation process improves patients' ability to start and remain on treatment.