Eli Lilly’s IL-23p19 inhibitor Omvoh (mirikizumab-mrkz) has been approved by the US Food and Drug Administration (FDA) to treat adults with moderately to severely active ulcerative colitis (UC).
The decision makes Omvoh the only UC treatment that selectively targets the p19 subunit of IL-23, which plays a role in inflammation related to the condition.
The approval was supported by results from the LUCENT programme, which included a 12-week induction study and a 40-week maintenance study, in adults with moderately to severely active UC.
All patients enrolled in the programme had received previous treatments, including biologic treatments, that did not work, stopped working or could not be tolerated.
After 12 weeks of treatment with Omvoh, 24% of patients achieved clinical remission, compared to 15% of those in the placebo group.
Among those who achieved clinical response at 12 weeks, 51% of all Omvoh-treated patients remained in clinical remission at one year, compared to 27% of those on placebo.
Additionally, 99% who achieved clinical remission at one year were steroid-free, and 39% had achieved resolution or near resolution of bowel urgency, which is reported by UC patients as one of the most disruptive symptoms of the condition.
Michael Osso, president and chief executive officer, Crohn’s and Colitis Foundation, said: “[The] approval of Omvoh offers new hope for those who have tried other therapies and still find themselves making accommodations for the uncertainty of bowel urgency-related accidents and other symptoms associated with UC.”
UC is a chronic, immune-mediated condition where the colon and rectum become inflamed, causing symptoms such as persistent diarrhoea and abdominal pain. The condition is one of the two main types of inflammatory bowel disease, which affects nearly one in every 100 people in the US.
Patrik Jonsson, Lilly executive vice president, president of Lilly Immunology and Lilly USA, and chief customer officer, said: “Omvoh addresses key symptoms that matter most to patients and represents our patient-centric approach to treatment innovation.
“Omvoh’s approval is a significant moment for Lilly’s growing Immunology portfolio, and we are excited to work with the gastroenterology community to set high expectations of care for people living with UC.”