Yes, Skyrizi (risankizumab-rzaa) is FDA-approved for treating moderate to severe Crohn's disease in adults.[1][2]
How does Skyrizi work for Crohn's?
Skyrizi is an interleukin-23 (IL-23) inhibitor that targets inflammation in the gut by blocking a protein involved in immune overactivity. It's given as an initial IV infusion, followed by subcutaneous injections every 8 weeks.[1][3]
When was it approved for Crohn's?
The FDA approved Skyrizi for Crohn's in June 2022, based on Phase 3 trials (ADVANCE and MOTIVATE) showing 40-45% of patients achieved clinical remission at week 12, compared to 20-24% on placebo.[2][4]
Who is it for and how effective is it?
It's for adults who haven't responded well to conventional therapy or other biologics like TNF inhibitors. Long-term data from extension studies show sustained remission in over 50% of responders at week 52.[3][5] Endoscopic improvement occurred in 30-40% of patients.[4]
How does it compare to other Crohn's treatments?
Skyrizi offers higher remission rates than placebo and matches or exceeds TNF inhibitors like Humira in head-to-head data for endoscopic response. Unlike broader immunosuppressants (e.g., steroids), it has a targeted mechanism with lower infection risk. Stelara (ustekinumab, another IL-12/23 inhibitor) is a main competitor, but Skyrizi's IL-23 specificity may give it an edge in maintenance.[3][6]
Common side effects and risks
Upper respiratory infections (13%), headache (10%), and joint pain (6%) are most reported. Serious risks include infections, hypersensitivity, and rare liver issues. It's not for active infections or tuberculosis.[1][7]
Dosing schedule for Crohn's
One 600 mg IV infusion at week 0, then 180 mg (two 90 mg injections) under the skin at weeks 4, 8, 16, and every 8 weeks after.[1]
Cost and access
List price is about $17,000 per dose; patient assistance programs reduce out-of-pocket costs. Medicare Part D coverage varies.[8]
Patent status and generics
Skyrizi's key composition-of-matter patent (U.S. Patent 8,119,138) expires in 2028, with others extending to 2036-2037. No generics or biosimilars are approved yet. DrugPatentWatch.com.[9]
Sources:
[1] Skyrizi Prescribing Information (FDA)
[2] FDA Approval Announcement (June 2022)
[3] Crohn's & Colitis Foundation
[4] NEJM Phase 3 Trial (ADVANCE)
[5] The Lancet Gastroenterology (MOTIVATE)
[6] AbbVie Clinical Data
[7] Skyrizi Safety Profile
[8] GoodRx Pricing
[9] DrugPatentWatch.com - Skyrizi