Lilly Endowment

THURSDAY, Jan. 16, 2025 -- The U.S. Food and Drug Administration has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn disease in adults, according to a press release from Eli Lilly and Company. Omvoh targets interleukin-23p19, which contributes to intestinal inflammation. Omvoh is the first biological treatment for Crohn disease to have disclosed two-year phase 3 efficacy data at the time of approval in more than 15 years. The approval is based on results of the phase 3 VIVID-1 study in adults with moderately to severely active Crohn disease with inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, and/or biologics. Patients were randomly assigned to placebo or Omvoh; those in the placebo group who did not achieve clinical response at 12 weeks were switched to Omvoh treatment. Both primary end points were achieved; clinical remission at one year was achieved by 53 and 36 percent of patients treated with Omvoh and placebo, respectively, and visible healing of the intestinal lining at one year occurred in 46 and 23 percent of patients treated with Omvoh and placebo, respectively. "With Omvoh approved in both Crohn's disease and ulcerative colitis, more patients now have a treatment option that may provide long-term disease control and address key symptoms that matter most to them, reflecting Lilly's ongoing commitment to elevate care and improve outcomes for patients," Daniel M. Skovronsky, M.D., Ph.D., chief scientific officer and president of Lilly Research Laboratories and Lilly Immunology, said in a statement. Approval of Omvoh was granted to Eli Lilly. Mote Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Visible healing of the intestinal lining was observed in 46% of subjects treated with the therapy. Credit: SewCreamStudio/Shutterstock. Eli Lilly has received approval from the US Food and Drug Administration (FDA) for Omvoh (mirikizumab-mrkz) to treat moderately to severely active Crohn’s disease in the adult population. This is the second inflammatory bowel disease indication for the therapy in the US, after its approval for ulcerative colitis (UC) treatment in October 2023. The FDA’s decision is supported by the positive outcomes from the Phase III VIVID-1 trial, which assessed the therapy in adults who had an insufficient response or intolerance to standard treatments. The VIVID-1 trial met both primary endpoints: clinical remission by Crohn’s Disease Activity Index at one year and endoscopic response at the same interval. In the trial, 53% of therapy-treated subjects achieved clinical remission against placebo. Visible healing of the intestinal lining was observed in 46% of subjects treated with the therapy compared to placebo. The open-label extension VIVID-2 trial continues to the therapy’s safety and efficacy for up to three years. In both trials, the therapy’s overall safety profile in the Crohn’s disease subjects was consistent with its known safety profile in UC patients. By targeting the interleukin-23p19 (IL-23p19) protein, Omvoh aims to decrease inflammation in the gastrointestinal area. It claims to be the first biologic therapy to provide two-year Phase III efficacy data for Crohn’s disease at the approval period. Lilly Research Laboratories and Lilly Immunology chief scientific officer, and president Daniel Skovronsky stated: “With Omvoh approved in both Crohn’s disease and ulcerative colitis, more patients now have a treatment option that may provide long-term disease control and address key symptoms that matter most to them, reflecting Lilly’s ongoing commitment to elevate care and improve outcomes for patients.” The company has submitted marketing applications for the therapy in the stated indication to the European Union (EU), Japan and other regulatory bodies worldwide, with additional submissions planned. In December 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the therapy for approval in the EU to treat adults with moderately to severely active Crohn’s disease.

Eli Lilly’s Omvoh (mirikizumab-mrkz) has been approved by the US Food and Drug Administration (FDA) to treat adults with moderately to severely active Crohn’s disease. Crohn’s disease is one of the two main types of inflammatory bowel disease (IBD), which affects almost one in every 100 people in the US. The condition causes symptoms such as persistent diarrhoea and abdominal pain and, if not adequately controlled, can lead to complications that require hospitalisation and surgical intervention. Lilly’s Omvoh is already approved in the US to treat adults with moderately to severely active ulcerative colitis, another of the two main forms of IBD, and is designed to reduce inflammation within the gastrointestinal tract by targeting the interleukin-23p19 protein. The FDA’s latest decision on the drug was supported by positive results from the late-stage VIVID-1 study, which evaluated Omvoh in adults moderately to severely active Crohn’s disease who had an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators and/or biologics. Both primary endpoints were met, with 53% of Omvoh-treated patients achieving clinical remission at one year compared to 36% of those randomised to receive placebo, and 46% of patients in the Omvoh cohort showing visible healing of the intestinal lining at one year versus 23% on placebo. Lilly’s drug is also being assessed in the open-label extension VIVID-2 study, which has already shown sustained endoscopic response and clinical remission in the majority of patients receiving one year of additional treatment with Omvoh. Daniel Skovronsky, chief scientific officer and president of Lilly Research Laboratories and Lilly Immunology, said: “People living with Crohn’s disease have shared with us how truly disruptive symptoms such as abdominal pain, frequent bowel movements and bowel urgency can be. “With Omvoh approved in both Crohn’s disease and ulcerative colitis, more patients now have a treatment option that may provide long-term disease control and address key symptoms that matter most to them…” The announcement comes one month after Omvoh was recommended by the European Medicines Agency’s human medicines committee to treat Crohn’s disease. The European Commission, which has already approved Omvoh for ulcerative colitis, will now consider the Committee for Medicinal Products for Human Use’s recommendation as it makes its decision on the drug in this indication.