FDA Approves Eli Lilly's Omvoh for Ulcerative Colitis Treatment

United States of America
Omvoh comes with a boxed warning about the risk of serious infections, malignancies, and a rare but serious condition that affects the brain.
The approval is based on the results of a Phase 3 clinical trial, LUCENT-1, which showed that Omvoh significantly improved clinical remission and endoscopic response rates compared to placebo.
The FDA has approved Eli Lilly's Omvoh for the treatment of adults with moderate to severe ulcerative colitis.

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's Omvoh (mirikizumab) for the treatment of adults with moderate to severe ulcerative colitis (UC). This approval marks the first of its kind for this class of medication. Omvoh is an injectable monoclonal antibody that targets the p19 subunit of interleukin 23, a cytokine that plays a key role in inflammatory processes.

The approval was based on the results of a Phase 3 clinical trial, LUCENT-1, which demonstrated that Omvoh significantly improved clinical remission and endoscopic response rates compared to placebo. The trial involved 1,118 patients with moderate to severe UC who had an inadequate response, loss of response, or intolerance to conventional or biologic therapy.

However, the drug's approval comes with a boxed warning about the risk of serious infections, malignancies, and a rare but serious condition that affects the brain. Patients are advised to seek immediate medical attention if they experience symptoms such as fever, night sweats, weight loss, fatigue, cough, shortness of breath, blood in phlegm, sores on the body, warm or painful areas on the body, diarrhea or stomach pain, burning when urinating, or urinating more often than normal.


Confidence

95%

Doubts
  • The exact side effects and long-term impacts of Omvoh are not fully detailed in the articles.

Sources

79%

  • Unique Points
    • Omvoh is the first and only FDA-approved treatment that selectively targets IL-23, a key driver of the inflammatory process in ulcerative colitis.
  • Accuracy
    No Contradictions at Time Of Publication
  • Deception (100%)
    None Found At Time Of Publication
  • Fallacies (100%)
    None Found At Time Of Publication
  • Bias (90%)
    • The article is written by Eli Lilly, the company that produces Omvoh, which could lead to a potential bias in favor of the product.
    • Site Conflicts Of Interest (20%)
      • The site is owned by Eli Lilly and Company, the pharmaceutical company that produces the drug Omvoh (mirikizumab). This could potentially bias the information presented.
      • Author Conflicts Of Interest (100%)
        None Found At Time Of Publication

      97%

      • Unique Points
        • The drug, called Omvoh, is the first to be approved that works by blocking a protein called interleukin 23.
      • Accuracy
        No Contradictions at Time Of Publication
      • Deception (100%)
        None Found At Time Of Publication
      • Fallacies (100%)
        None Found At Time Of Publication
      • Bias (95%)
        None Found At Time Of Publication
      • Site Conflicts Of Interest (100%)
        None Found At Time Of Publication
      • Author Conflicts Of Interest (100%)
        None Found At Time Of Publication

      95%

      • Unique Points
        • The approval of Omvoh is based on results from a Phase 3 study, which showed that the drug significantly improved symptoms of ulcerative colitis compared to a placebo.
      • Accuracy
        No Contradictions at Time Of Publication
      • Deception (100%)
        None Found At Time Of Publication
      • Fallacies (100%)
        None Found At Time Of Publication
      • Bias (90%)
        • The article is published on a financial news website, which could potentially bias the information towards the financial implications of the FDA approval.
        • Site Conflicts Of Interest (100%)
          None Found At Time Of Publication
        • Author Conflicts Of Interest (100%)
          None Found At Time Of Publication