FDA approves subcutaneous induction regimen of AbbVie’s SKYRIZI for Crohn’s disease
+1 new source since this summary was written
The U.S. Food and Drug Administration cleared a new subcutaneous induction option for AbbVie’s SKYRIZI (risankizumab‑rzaa) in adults with moderately to severely active Crohn’s disease. The decision is based on the Phase 3 AFFIRM trial, which showed significantly higher clinical remission and endoscopic response rates versus placebo, especially in patients without prior advanced‑therapy failure. The regimen lets patients start treatment at home using an on‑body injector, with the initial four induction doses given at the start and then continued with regular maintenance dosing.
Why it matters
The approval expands SKYRIZI’s administration routes, giving patients a home‑based option that may improve adherence and convenience. AbbVie expects the new formulation to broaden its immunology portfolio and potentially increase SKYRIZI sales, according to the company’s press release.
Key facts
- 1The FDA approved a subcutaneous induction regimen for SKYRIZI in adults with moderately to severely active Crohn’s disease. news.abbvie.com
- 2The approval relies on the Phase 3 AFFIRM study, which demonstrated superiority of clinical remission and endoscopic response at week 12 compared with placebo. news.abbvie.com
- 3In patients without prior advanced‑therapy failure, 74% achieved clinical remission versus 27% on placebo. news.abbvie.com
- 4In the same advanced‑therapy‑naïve group, endoscopic response was 60% versus 15% on placebo. news.abbvie.com
- 5The induction dosing schedule consists of 720 mg administered via an on‑body injector at the start and then at weeks 2, 4 and 8, followed by maintenance dosing every eight weeks. gurufocus.com
- 6The FDA also updated SKYRIZI’s prescribing information to allow clinicians to use judgment on tuberculosis testing rather than requiring it. stocktitan.net
Summary written by AlphAI AI Desk from 7 of 7 sources. Not investment advice. Figures are as stated by the linked sources.