FDA-Approved Treatments
Current approved therapies — what they are, who makes them, and what to ask your doctor.
FDA-approved for moderate-to-severe Crohn's disease (2022). IL-23 inhibitor — targets the p19 subunit of IL-23. Phase 3 trials showed ~45% clinical remission at 12 weeks induction, ~52% at 52 weeks maintenance.
Approved for moderate-to-severe Crohn's disease (2016). Dual IL-12/23 blocker. Well-established safety profile with long-term data. Biosimilars (Wezlana, Selarsdi) now available at lower cost.
Gut-selective biologic — blocks α4β7 integrin. FDA-approved for Crohn's disease (2014). Favorable safety profile due to gut-restricted mechanism. Available as both IV and subcutaneous formulation.
FDA-approved for moderate-to-severe Crohn's disease (2023). First oral targeted therapy approved for Crohn's. JAK1-selective inhibitor — faster onset than biologics. ~39% clinical remission at 12 weeks, ~46% at 52 weeks.
First-line biologic for moderate-to-severe Crohn's disease. TNF-alpha inhibitor — well-established 20+ year track record. Multiple biosimilars now available at significantly lower cost.
Community Feed
What patients and caregivers are saying about Crohn's Disease
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Go to Pulse →Newly diagnosed with Crohn's disease? What to do first.
An IBD specialist will know the current biologic options, treat-to-target strategies, and navigate insurance. The Crohn's & Colitis Foundation (crohnscolitisfoundation.org) has a 'Find a Doctor' directory.
Not all Crohn's is the same. Your GI needs to assess: which parts of the GI tract are involved, disease severity, presence of fistulas or strictures, perianal involvement, and inflammatory markers. Colonoscopy + imaging (CT or MR enterography) is typically needed for full disease mapping.
The old step-up approach is outdated for moderate-to-severe disease. Early biologic therapy prevents complications and improves long-term outcomes. Ask about Skyrizi, Stelara, or Entyvio as first-line advanced therapy.
Mucosal healing is now the treatment target in Crohn's. You need a baseline to measure progress. Regular monitoring is needed to assess treatment response. Don't skip the colonoscopy even when you feel better.
AbbVie (Skyrizi), J&J (Stelara), Takeda (Entyvio), and multiple biosimilar makers all have patient assistance programs. The Crohn's & Colitis Foundation has the IBD Help Center (888-694-8872) and financial assistance resources.
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Frequently Asked Questions
Real questions from patients and caregivers — answered in plain English.