Lilly's Omvoh (mirikizumab-mrkz) meets primary endpoint of clinical remission and is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric ulcerative colitis

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  "signal_type": "news",
  "signal_subtype": "is_developing",
  "detected_at": "2026-10-19T08:40:00+00:00",
  "company": {
    "name": "Eli Lilly",
    "domain": "lilly.com"
  },
  "data": {
    "url": "https://www.prnewswire.com/news-releases/lillys-omvoh-mirikizumab-mrkz-meets-primary-endpoint-of-clinical-remission-and-is-the-first-il-23p19-inhibitor-to-report-one-year-phase-3-results-in-pediatric-ulcerative-colitis-302911320.html",
    "title": "Lilly's Omvoh (mirikizumab-mrkz) meets primary endpoint of clinical remission and is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric ulcerative colitis",
    "ticker": "NYSE:LLY",
    "excerpt": "Building on Omvoh's approved use and durable efficacy in adults, Lilly plans to submit these data to global regulators to support a potential label expansion for pediatric ulcerative colitis More than 80% of patients responded to Omvoh induction, and half of responders, ages 6 to 17, were in clinical remission at one year in Phase 3 SHINE-2 study In key secondary outcomes, 71.2% of patients who responded to Omvoh induction achieved symptomatic remission and 50% achieved corticosteroid-free clinical remission at one year without surgery INDIANAPOLIS , Oct. 19, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY ) today announced positive late-breaking one-year results from the Phase 3 SHINE-2 study of Omvoh (mirikizumab-mrkz) in pediatric patients ages 6 to 17 with moderately to severely active ulcerative colitis (UC), including clinical, symptomatic and endoscopic outcomes. In the single-arm, open-label study, 81% of patients achieved clinical response to Omvoh induction at Week 12. Among responders, 50% achieved clinical remission at Week 52, meeting the study's primary endpoint.* Omvoh is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric UC. These results were presented as a late-breaking oral presentation at United European Gastroenterology (UEG) Week 2026. 1 Omvoh is currently approved for adults with moderately to severely active UC. The...",
    "product": "Omvoh",
    "summary": "Eli Lilly and Company reported positive Phase 3 SHINE-2 study results for Omvoh (mirikizumab-mrkz) in pediatric patients with active ulcerative colitis, meeting its primary endpoint.",
    "location": "Indianapolis, Indiana, United States",
    "planning": false,
    "image_url": "https://mmx.prnewswire.com/media/MS270365/ELI-LILLY-AND-COMPANY-LOGO.jpg?id=OA3018517&p=facebook",
    "confidence": 0.95,
    "product_data": {
      "name": "Omvoh",
      "full_text": "Omvoh (mirikizumab-mrkz)",
      "fuzzy_match": false
    },
    "product_tags": [
      "medical"
    ],
    "published_at": "2026-10-19T08:40:00Z",
    "location_data": [
      {
        "city": "Indianapolis",
        "state": "Indiana",
        "region": "Northern America",
        "country": "United States",
        "continent": "Americas",
        "fuzzy_match": false
      }
    ],
    "effective_date": "2026-10-19",
    "article_sentence": "INDIANAPOLIS , Oct. 19, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY ) today announced positive late-breaking one-year results from the Phase 3 SHINE-2 study of Omvoh (mirikizumab-mrkz) in pediatric patients ages 6 to 17 with moderately to severely active ulcerative colitis (UC), including clinical, symptomatic and endoscopic outcomes."
  }
}

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