US major Eli Lilly and Company (NYSE: LLY) has announced receiving marketing approval from the US FDA for its Omvoh (mirikizumab-mrkz), an interleukin-23p19 (IL-23p19) antagonist, to treat moderately to severely active Crohn’s disease in adults. This approval follows the FDA’s nod for its use as a first-in-class treatment for moderately to severely active ulcerative colitis (UC) in adults in October 2023.
FDA Decision and Study Results
The FDA’s decision was based on results from the VIVID-1 study, a randomized, double-blinded, placebo-controlled Phase III study. The study assessed the efficacy and safety of Omvoh in adult patients with moderate to severe active Crohn’s disease (CD) who had an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, and methotrexate), and/or biologics (TNF blockers, integrin receptor antagonists). In the study, the clinical remission rate (53% vs 36%) and endoscopic response rate (46% vs 23%) of patients receiving Omvoh were significantly higher versus placebo after one-year treatment, meeting both primary endpoints.
Long-Term Efficacy and Safety
In addition to the VIVID-1 study, Omvoh is being assessed for efficacy and safety for up to three years in adults with moderately to severely active CD in the open-label extension (OLE) VIVID-2 study. Preliminary results have shown that among patients who achieved endoscopic response at one year, over 80% maintained endoscopic response with one year of additional treatment (two years of continuous treatment). These results highlight the potential long-term benefits of Omvoh in managing Crohn’s disease.
Strategic Implications
The FDA’s approval of Omvoh for Crohn’s disease marks a significant milestone for Eli Lilly and Company. It underscores the company’s commitment to advancing innovative treatments for inflammatory bowel diseases and enhancing patient outcomes. By expanding its portfolio with this new indication, Eli Lilly aims to address significant unmet medical needs and improve the quality of life for patients with Crohn’s disease.-Fineline Info & Tech
Leave a Reply