The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's Omvoh (mirikizumab) for the treatment of adults with moderate to severe ulcerative colitis (UC). This approval marks the first of its kind for this class of medication. Omvoh is an injectable monoclonal antibody that targets the p19 subunit of interleukin 23, a cytokine that plays a key role in inflammatory processes.
The approval was based on the results of a Phase 3 clinical trial, LUCENT-1, which demonstrated that Omvoh significantly improved clinical remission and endoscopic response rates compared to placebo. The trial involved 1,118 patients with moderate to severe UC who had an inadequate response, loss of response, or intolerance to conventional or biologic therapy.
However, the drug's approval comes with a boxed warning about the risk of serious infections, malignancies, and a rare but serious condition that affects the brain. Patients are advised to seek immediate medical attention if they experience symptoms such as fever, night sweats, weight loss, fatigue, cough, shortness of breath, blood in phlegm, sores on the body, warm or painful areas on the body, diarrhea or stomach pain, burning when urinating, or urinating more often than normal.