Lilly's Omvoh meets primary endpoint in pediatric ulcerative colitis trial

Overview

Updated 2 hours ago

Children with ulcerative colitis have fewer approved drugs than adults, and new treatment classes reach them years later. On October 19, Eli Lilly reported Phase 3 data that could narrow that gap: half of pediatric responders to Omvoh (mirikizumab) were in clinical remission at one year.

The SHINE-2 study enrolled 63 patients ages 4 to 17, 54% of whom had already failed a biologic. Among week-12 responders, 50% reached remission at week 52, 71.2% hit symptomatic remission, and 44.2% achieved endoscopic remission. No new safety signals appeared.

These are the first one-year Phase 3 results for any IL-23 inhibitor in pediatric ulcerative colitis. Lilly plans to submit the data to global regulators for a pediatric label; if approved, Omvoh would be the first drug in its class available to children.

Why it matters

If approved, Omvoh would give children with ulcerative colitis a first-in-class IL-23 option, currently adult-only, potentially reducing steroid use and surgery.

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Key Indicators

50%

Clinical remission at week 52 among week-12 responders

Primary endpoint met; matches the 50.7% rate in adults from LUCENT-2.

81%

Clinical response to induction at week 12

In a study where 54% of patients had already failed a biologic.

Patients enrolled in SHINE-2

Ages 4 to 17 with moderately to severely active ulcerative colitis.

54%

Patients with prior biologic failure

Roughly half the cohort had exhausted advanced therapy.

44.2%

Endoscopic remission at week 52

Among week-12 responders, per the endoscopic subscore of 0.

Voices

Curated perspectives — historical figures and your fellow readers.

Ever wondered what historical figures would say about today's headlines?

Organizations Involved

Eli Lilly and Company

Pharmaceutical company

Sponsor of SHINE-2; preparing regulatory submission for pediatric label

U.S. drugmaker whose Omvoh (mirikizumab), an IL-23p19 antagonist, is approved for adults with ulcerative colitis and Crohn's disease in 47 countries.

Timeline

1 event Latest: Today

October 2026
SHINE-2 one-year results presented at UEG Week 2026
Today Clinical Data

Among 52 week-12 responders ages 6 to 17, 50% reached clinical remission at week 52, meeting the primary endpoint against an adult-derived benchmark.
Today

Scenarios

FDA approves Omvoh for pediatric ulcerative colitis

Likely Resolves by Q2 2028

Discussed by: Eli Lilly in its investor release; industry analysts following the UEG Week presentation

Lilly submits SHINE-2 data to the FDA and European Medicines Agency. The 50% remission rate matching adults, plus a clean safety profile, supports a standard priority-review timeline of roughly 10 to 12 months. Approval would make Omvoh the first IL-23p19 inhibitor indicated for pediatric UC.

Regulators request additional pediatric data before approval

Possible Resolves by Q2 2028

Discussed by: Physician commentary at UEG Week; regulatory-watch analysts

The single-arm, open-label SHINE-2 design lacks a placebo control, so the FDA may ask for longer-term safety follow-up or additional enrollment before granting a pediatric label. A complete response letter would delay the expansion, not necessarily kill it.

Long-term extension confirms remission holds past one year

Likely Resolves by End of 2028

Discussed by: Lilly's ongoing study program; pediatric IBD investigators

The long-term extension study (NCT04844606) tracks durability of response beyond week 52. If remission holds at two years with no new safety signals, it strengthens the case for pediatric labeling and for broader use in children who have failed biologics.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

May 2006

Infliximab becomes first biologic approved for pediatric Crohn's (2006)

The FDA approved infliximab (Remicade) for children with Crohn's disease, eight years after adults first received it in 1998. It was the first biologic cleared for any pediatric inflammatory bowel disease, used in patients who had failed conventional therapy.

Then

Clinics gained a non-surgical option for severe pediatric Crohn's; dosing had to be adjusted for children's weights and growth.

Now

Set the template for pediatric IBD evidence: small open-label studies following adult efficacy data, with approvals arriving years after the adult indication.

Why this matters now

Omvoh follows the same adult-first path, but SHINE-2 produced one-year randomized-grade data early enough to narrow the usual multi-year lag between adult and pediatric approvals.

September 2011

FDA approves infliximab for pediatric ulcerative colitis (2011)

Six years after its adult ulcerative colitis approval, infliximab was cleared for children with moderately to severely active UC who had not responded to conventional therapy. The decision rested on a relatively small pediatric study.

Then

Gave pediatric gastroenterologists a second-line biologic for UC and reduced colectomy rates in responders.

Now

Demonstrated that pediatric efficacy could mirror adult results, encouraging drugmakers to plan pediatric trials earlier in a molecule's life.

Why this matters now

It is the closest precedent to what Lilly seeks: a class-leading biologic extended from adults to children with ulcerative colitis, where the medical need is severe and options are thin.