Can skyrizi be used for ulcerative colitis in 2026?

Can Skyrizi be approved for ulcerative colitis in 2026?

Skyrizi is a monoclonal antibody that blocks interleukin-23. Current approvals cover plaque psoriasis, psoriatic arthritis, and Crohn’s disease. Ulcerative colitis is not among them.

Why has ulcerative colitis not been approved yet?

AbbVie’s phase 3 program for ulcerative colitis has completed enrollment, but results are still pending. Regulators normally require two adequate and well-controlled trials before granting approval. Until those data are submitted and reviewed, the indication remains off-label.

When could approval occur if the trials succeed?

Positive data readouts are expected in late 2025. Standard FDA review takes 10 months for standard applications and 6 months for priority review. If AbbVie files in early 2026 and receives priority review, a decision could land by the end of 2026. A standard review would push the earliest approval into 2027.

How does Skyrizi compare with approved ulcerative colitis drugs?

Stelara and Entyvio are already approved for ulcerative colitis. Both target different immune pathways. Skyrizi’s IL-23 blockade may offer dosing every 8–12 weeks after induction, which is less frequent than Entyvio’s every-8-week infusion schedule. Head-to-head data are not yet available.

Can biosimilars or competing IL-23 agents reach the market sooner?

Ustekinumab biosimilars for Stelara are expected in 2025. Guselkumab and mirikizumab, both IL-23 inhibitors, are in phase 3 for ulcerative colitis and could file before Skyrizi. Any of these products could limit Skyrizi’s first-mover advantage if approved earlier.

What happens to patients who want Skyrizi before approval?

Prescribers may continue off-label use where medically justified. Insurance coverage, however, is unlikely without an FDA-approved indication. Clinical-trial enrollment remains the only insured route for most patients until a label expansion occurs.

When does Skyrizi’s patent protection end?

Skyrizi’s composition-of-matter patent expires in 2033 in the United States. Earlier loss of exclusivity is possible only through successful patent challenges or settlement. AbbVie has already listed additional formulation and dosing patents that could extend protection into the mid-2030s.

DrugPatentWatch.com