Mirikizumab

Dive Brief:Eli Lilly won Food and Drug Administration approval to sell its Omvoh medicine for adults with Crohns disease, adding to the potential market for a drug first approved in 2023.Omvoh is already available for adults with ulcerative colitis, a more common form of inflammatory bowel disease. Overall, IBD affects about 2.4 million Americans, according to a recent study, with Crohns and ulcerative colitis being the most common.The approval is based on a study that found Omvoh could help patients whose disease wasnt adequately controlled by previous treatments. However, two of the three largest pharmacy benefit managers have listed it as a first-line therapy, not requiring patients to have failed on another drug first, Lilly said Wednesday.Dive Insight:Omvoh is part of a slate of new medicines designed to build on Lillys success with diabetes and obesity treatments that have boosted earnings and sent its shares soaring. The company won approval in colitis in October 2023, after an initial rejection in April 2023 based on manufacturing issues.Drugmakers have been pouring money into the gastrointestinal field in recent years and expanding the use of blockbusters such as AbbVies Skyrizi to include colitis and Crohns disease. Like Skyrizi, Omvoh is designed to target a specific subunit of the IL-23 protein to prevent inflammation. J&Js Tremfaya also blocks IL-23 while binding to the CD64 receptor on cells that produce IL-23 as well.While Omvohs sales have been relatively modest to date, with revenue of $41 million in the third quarter, Lilly touted its potential for growth in guidance released Tuesday. Overall, the company said 2024 revenue increased less than it previously estimated; Lilly is due to report full results on Feb. 6.In its approval announcement Wednesday, Lilly said Omvoh is the first biologic in more than 15 years to enter the market after sharing two years worth of Phase 3 efficacy data in Crohns disease. Almost 90% of patients who achieved clinical remission and endoscopic response in the first year of treatment with Omvoh maintained that status through an additional year in an ongoing open-label extension study, Lilly said.Editors note: This story has been updated to clarify the percent of patients who continued to benefit through an additional year of follow-up. '

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.