U.S. FDA Approves Subcutaneous Induction Regimen for AbbVie's SKYRIZI® (risankizumab-rzaa) for Adults With Moderately to Severely Active Crohn's Disease
The FDA approved a subcutaneous induction regimen for AbbVie's SKYRIZI in adults with moderately to severely active Crohn's disease, allowing patients to start treatment at home via an on-body injector. In the pivotal Phase 3 AFFIRM trial, SC SKYRIZI beat placebo on both co-primary endpoints at week 12; in advanced therapy-naive patients, 74% achieved clinical remission versus 27% on placebo, with endoscopic response four times placebo (60% vs 15%).
Key figures
- Drug Name
- SKYRIZI (risankizumab-rzaa)
- Phase Of Trial
- Phase 3
- Affirm patients randomized
- 274
- Clinical remission total placebo
- 30%
- Clinical remission total skyrizi
- 56%
- Clinical remission at naive placebo
- 27%
- Clinical remission at naive skyrizi
- 74%
- Endoscopic response at naive placebo
- 15%
- Endoscopic response at naive skyrizi
- 60%
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.