FDA clears new SC induction for AbbVie’s Skyrizi

The U.S. Food and Drug Administration has approved a subcutaneous induction regimen for AbbVie (ABBV)’s SKYRIZI (risankizumab-rzaa) for adults with moderately to severely active Crohn’s disease. The new regimen enables patients to begin treatment at home using an on-body injector, adding a fully self-administered option from the start of therapy.

Under the approved subcutaneous induction schedule, patients receive 720 mg of SKYRIZI delivered by an on-body injector induction pack at weeks 0, 2, 4 and 8. Maintenance dosing then starts at week 12 and is administered every eight weeks, also using the on-body injector device.

Patients continue to have the option to initiate SKYRIZI intravenously with 600 mg infusions at weeks 0, 4 and 8. After either induction route, ongoing maintenance can be given subcutaneously every eight weeks starting at week 12.

The FDA decision is supported by results from the Phase 3 AFFIRM trial, a randomized, placebo-controlled, double‑blind study in adults with moderately to severely active Crohn’s disease. The trial enrolled 274 patients, who were randomized in a 2:1 ratio to receive subcutaneous SKYRIZI or placebo; 65% of participants had previously failed advanced therapies, reflecting a treatment‑refractory population.

AFFIRM met its co‑primary endpoints of clinical remission and endoscopic response at week 12. In the total study population, 56% of patients treated with subcutaneous SKYRIZI achieved clinical remission compared with 30% on placebo. Endoscopic response was observed in 43% of SKYRIZI‑treated patients versus 15% of those receiving placebo at week 12.

Efficacy was higher in patients without prior advanced therapy failure. In this subgroup, 74% of patients on subcutaneous SKYRIZI achieved clinical remission at week 12 compared with 27% on placebo, and 60% achieved an endoscopic response versus 15% on placebo. These results indicate particularly strong responses in treatment‑naïve or less refractory patients.

The safety profile of the subcutaneous induction regimen was generally consistent with the established SKYRIZI safety profile in Crohn’s disease. No new safety risks were identified in the AFFIRM study, aligning the subcutaneous induction experience with prior data for the medicine.

Alongside the new induction approval, the FDA also approved an update to SKYRIZI’s U.S. prescribing information across all approved indications. The revised warning and precautions language allows healthcare providers to use clinical judgment when deciding whether tuberculosis testing is needed before starting treatment, removing the previous requirement for mandatory TB testing.

SKYRIZI is an interleukin‑23 inhibitor that selectively binds to the p19 subunit of IL‑23 and is already approved for several immune‑mediated conditions, including Crohn’s disease. The new subcutaneous induction option, combined with updated labeling on TB evaluation, broadens how clinicians can initiate and manage SKYRIZI therapy in adults with moderately to severely active Crohn’s disease.