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The drug is already approved in the US to treat ulcerative colitis, another form of inflammatory bowel 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.
