AbbVie’s Skyrizi extends its IL-23 role into ulcerative colitis

The Tip Desk · September 23, 2026 · 1 min read

The approved indication rests on distinct induction and maintenance studies, with longer follow-up continuing.

Risankizumab, marketed as Skyrizi and linked to the research names BI 655066 and ABBV-066, is an IL-23 antibody. FDA's 2024 supplemental approval letter establishes the ulcerative-colitis indication. Its prior development and use in other conditions should remain separate from the specific evidence supporting UC.

The induction study used intravenous treatment and a 12-week remission endpoint. Its companion maintenance study used subcutaneous treatment and a week-52 remission assessment, with longer follow-up retained in the registry. The induction record is completed, while the maintenance record remains active but not recruiting in the retrieved snapshot. Those different states do not imply different regulatory status for the compound.

The published pivotal trial report provides efficacy and safety results for these defined designs. It is a more appropriate basis for an evidence comparison than the registry's recruitment label. Comparisons with mirikizumab or investigational mechanisms still require attention to prior treatment, induction response selection, remission definitions and follow-up. No head-to-head superiority conclusion is made here.

Longer-term follow-up can add useful information after approval, but this account does not assign a speculative next readout date. An approved product can support a commercial business while still requiring investment and ongoing safety evaluation; corporate profitability does not settle a clinical comparison.

AbbVie reported $6.569 billion of cash and equivalents at June 30, $8.341 billion of current debt and $62.481 billion of long-term debt, with no short-term borrowing balance. First-half operating cash flow was $7.265 billion and net earnings $4.313 billion. The medicine sits within a commercial portfolio that generates cash but also supports debt service, acquisitions and other development programs. Neither the cash balance nor group earnings disclose a compound-specific funding commitment.