‘High efficacy’: Subcutaneous risankizumab sustains Crohn’s remission, response at week 24
AbbVie's risankizumab (Skyrizi) showed higher clinical remission and endoscopic response rates at week 12 and 24 in Crohn's disease patients compared to placebo, per a phase 3 AFFIRM study. The drug demonstrated a similar safety profile to other indications, according to a presentation at the ACG Annual Scientific Meeting. The study enrolled 289 adults with moderate to severe Crohn's disease, with primary endpoints being clinical remission and endoscopic response at week 12.
How this was made
The 30-second read
Why it matters
Positive data could expand the drug's label, increase market share, and drive revenue growth.
Market read
First report of significant Phase 3 results for a new Crohn's indication; likely to affect AbbVie stock and biotech sector.
What to watch
Potential reimbursement challenges and need for larger Phase 3 confirmatory studies.
Background
AbbVie’s Skyrizi is already approved for ulcerative colitis and psoriasis; this trial explores subcutaneous induction for Crohn's disease.
Ticker impact
Phase 3 AFFIRM trial shows subcutaneous risankizumab significantly improves remission and endoscopic response versus placebo in Crohn's disease.
likely upward pressure as market prices in potential label expansion and increased sales opportunity
First disclosure of robust Phase 3 results for a new indication; historically such data moves biotech stocks.
Market effects
strengthens outlook for IBD therapeutics and may lift peers in the biologics space.
U.S. biotech sector could see modest gains.
adds to global pipeline confidence for IL-23 inhibitors.
Counterpoint
Investors may question commercial viability given existing competition and pricing pressures.
Key entities
- CompanyAbbVie
Pharmaceutical company developing risankizumab (Skyrizi).
- IndividualDr. Millie D. Long
Gastroenterology professor presenting the trial results.
