FDA Clears At-Home Subcutaneous Induction for Skyrizi in Crohn's Disease
ABBV sits 50% above its 52-week low of $190.75.
Summary
The FDA approved a subcutaneous induction regimen for Skyrizi in moderately to severely active Crohn's disease, letting patients start treatment at home with an on-body injector instead of an IV infusion. The subcutaneous induction schedule is 720 mg at weeks 0, 2, 4 and 8, while the IV option of 600 mg at weeks 0, 4 and 8 remains available; after IV induction, patients transition to maintenance dosing beginning at Week 12, and maintenance continues with an on-body injector every eight weeks after subcutaneous induction. The approval rests on the Phase 3 AFFIRM trial, where 74% of advanced-therapy-naive patients on subcutaneous Skyrizi hit clinical remission at week 12 versus 27% on placebo, and 60% achieved endoscopic response versus 15%. That convenience angle matters commercially: Skyrizi and Rinvoq drove AbbVie's 10% revenue growth to $16.99B in Q2, and a fully self-administered option removes an infusion-center hurdle that can slow uptake. The FDA also loosened the label's TB language across all indications, dropping the mandatory test before starting treatment. This is an incremental label expansion rather than a new drug, so the near-term revenue impact is modest, but it strengthens Skyrizi's position in a competitive IBD market.
Updated with a dpa-AFX report · What changed
Updates
· dpa-AFX — The subcutaneous induction schedule is 720 mg at weeks 0, 2, 4 and 8, with the IV option of 600 mg at weeks 0, 4 and 8 remaining available.
- Continue maintenance treatment with an on-body injector (OBI) every eight weeks after subcutaneous induction.
- After IV induction, transition to maintenance dosing beginning at Week 12.
At the time of this announcement, ABBV was trading at $285.86 on NYSE in the Life Sciences sector, with a market capitalization of approximately $505.1B. The 52-week trading range was $190.75 to $291.40. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: PR Newswire.