AbbVie wins FDA approval for at-home Skyrizi initiation

The Tip Desk · Companies · October 24, 2026 · 2 min read

The clearance gave adults with Crohn’s disease an option to start Skyrizi at home and continue using an on-body injector through maintenance treatment.

Drugmaker AbbVie (ABBV) said on Oct. 23 that the U.S. Food and Drug Administration had approved subcutaneous induction of Skyrizi for adults with moderately to severely active Crohn’s disease, allowing patients to begin treatment at home using an on-body injector. The approval extended self-administration to the initial treatment phase.

The clearance expanded administration options for a medicine whose worldwide net revenue totaled $9.99 billion in the first half of 2026, compared with $7.85 billion a year earlier. Skyrizi’s approved uses included Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, the company said.

For Crohn’s patients, the new option connected treatment initiation with an established method of administering maintenance doses. AbbVie said patients could start with an on-body injector induction pack and continue using an injector during maintenance. Intravenous induction remained available, giving patients and healthcare providers another route for beginning the medicine.

AbbVie had introduced the Skyrizi on-body injector for Crohn’s maintenance treatment in 2022. The company cited a real-world survey of 186 people with Crohn’s disease in which 88% reported that the device was easy to use. Those findings concerned experience with the injector already used in clinical practice.

The approval was supported by AFFIRM, a randomized, double-blind Phase 3 study that compared subcutaneous induction with placebo in 274 adults. The trial enrolled a population in which 65% had previously failed advanced therapies for Crohn’s disease, according to the company. Those prior failures included inadequate response, loss of response or intolerance to biological treatments or Janus kinase inhibitors.

At week 12, clinical remission occurred in 56% of patients receiving subcutaneous Skyrizi, compared with 30% receiving placebo. The medicine also achieved superiority on the other co-primary endpoint, endoscopic response, which assessed improvement in intestinal disease activity. AbbVie said the treatment met secondary endpoints covering endoscopic remission and fatigue scores.

Results were stronger among patients without prior advanced therapy failure: 74% achieved clinical remission, compared with 27% receiving placebo. That group included patients who had never received biologics or Janus kinase inhibitors, as well as patients who had received them without failure or intolerance. AbbVie also reported higher efficacy responses than placebo among patients who had previously failed advanced therapy.

The company said the safety profile of subcutaneous induction was generally consistent with Skyrizi’s established profile in Crohn’s disease, with no new safety risks identified in the study.

For patients starting through the newly approved route, the regimen called for 720 milligrams through an on-body injector induction pack at weeks zero, two, four and eight. Maintenance treatment could then begin at week 12, with an on-body injector dose every eight weeks, the company said.