Omvoh granted FDA approval for ulcerative colitis
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). Inflammatory bowel disease is estimated to affect nearly one in every 100 people in the US.
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.