FDA approves at-home injection option to start AbbVie's Skyrizi in Crohn's disease

AbbVie said Friday that the U.S. Food and Drug Administration approved a new way to start its immunology drug Skyrizi in Crohn's disease: injections under the skin that patients can give themselves at home.

Until now, adults with moderately to severely active Crohn's disease began Skyrizi with intravenous infusions. The approved regimen delivers 720 mg doses through an on-body injector at weeks 0, 2, 4 and 8, followed by the same device every eight weeks for maintenance, according to the company's press release. Patients can still choose to start with 600 mg IV doses at weeks 0, 4 and 8.

"With the approval of subcutaneous induction, we are building on the strong efficacy of SKYRIZI while giving patients and physicians greater flexibility in how treatment is initiated," said Roopal Thakkar, AbbVie's chief scientific officer.

What the trial showed

The approval rests on the Phase 3 AFFIRM study, where subcutaneous Skyrizi beat placebo on both co-primary goals at week 12, AbbVie said. Across all patients, 56% on Skyrizi reached clinical remission versus 30% on placebo, and 43% had an endoscopic response versus 15%.

Results were strongest in patients who had not failed an earlier advanced therapy: 74% reached clinical remission versus 27% on placebo. AbbVie said the safety profile was consistent with Skyrizi's known profile in Crohn's disease, with no new safety risks.

A label change, too

The FDA also approved updated tuberculosis language across all of Skyrizi's approved uses. The revised label advises doctors to consider TB evaluation before starting treatment based on clinical judgment, and there is no mandatory TB test before starting the drug, AbbVie said.

By the numbers

• Clinical remission at week 12: 56% vs. 30% placebo
• Endoscopic response at week 12: 43% vs. 15% placebo
• Remission in advanced-therapy-naive patients: 74% vs. 27%
• Induction dose: 720 mg at weeks 0, 2, 4 and 8
• Maintenance: on-body injector every eight weeks

Sources

1. AbbVie Inc., press release, "U.S. FDA Approves Subcutaneous Induction Regimen for AbbVie's SKYRIZI (risankizumab-rzaa) for Adults With Moderately to Severely Active Crohn's Disease," Oct. 23, 2026

This article is for informational and educational purposes only and is not investment advice. It is not a recommendation to buy or sell any security.

Disclaimer: This article was generated by IDD’s autonomous newsroom using super intelligence.