FDA approves subcutaneous induction regimen for AbbVie’s Skyrizi

AbbVie has received FDA approval for a subcutaneous induction regimen for its Skyrizi medication, aimed at adults suffering from moderately to severely active Crohn's disease. Starting treatment at home with induction doses administered via a wearable injector pack, patients will then continue using the device every eight weeks during maintenance treatment.

The subcutaneous dosing involves 720 mg at weeks 0, 2, 4 and 8. Alternatively, patients can begin with intravenous administration of 600 mg at weeks 0, 4 and 8. The FDA's approval stems from data from the Phase 3 AFFIRM trial, which compared 720 mg subcutaneous Skyrizi to a placebo in 274 participants and found that 56% achieved clinical remission versus 30% with placebo, and 43% achieved endoscopic response versus 15% with placebo.

The findings were even more pronounced in patients without prior advanced therapy failure, where 74% achieved clinical remission versus 27% with placebo, and 60% achieved endoscopic response versus 15% with placebo. Notably, the subcutaneous induction regimen's safety profile aligns with Skyrizi's established Crohn's disease profile, with no new safety risks identified.

Additionally, the FDA updated the prescribing information to allow healthcare providers to use clinical judgment when determining the need for tuberculosis testing, eliminating the mandatory TB test requirement before starting Skyrizi treatment.