Is Mirikizumab already on the market?

Mirikizumab-Omvohdeveloped by Eli Lilly and Company (Eli Lilly), as a monoclonal antibody drug for ulcerative colitis, has attracted much attention in recent years. This drug interferes with the activity of pro-inflammatory cytokines and reduces the resulting inflammatory response by inhibiting the action of interleukin-23 (IL-23), which has important clinical significance.

Milizumab has been approved for marketing in many countries. The drug was first approved in Japan. Subsequently,In May 2023, militizumab received marketing authorization from the European Medicines Agency (EMA); in July of the same year, Canada also officially approved the use of the drug. Finally, in October 2023, militizumab also successfully passed approval in the United States, allowing it to be used under the trade name Omvoh to treat adult patients with moderately to severely active ulcerative colitis. The current launch of this drug on the global market marks a new option for treating the disease, but as of January 2025, militizumab has not yet been launched in the Chinese market.

MilizumabThe FDA approval was based on the results of a study called "LUCENT." The program includes two randomized, double-blind, placebo-controlled Phase 3 clinical trials, UC-1 and UC-2. Among them, UC-1 is a 12-week induction study, and UC-2 is a 40-week maintenance study. The entire treatment process lasts 52 weeks. The results of the study showed that after 12 weeks of Omvoh treatment, nearly two-thirds (65%) of patients in the placebo group achieved clinical remission, and nearly a quarter (24%) of patients achieved complete clinical remission. Specifically, the clinical remission rate and complete clinical remission rate were 43% and 15% respectively. These data demonstrate that militizumab has a significant effect in improving patients' condition and provide new hope for the majority of patients with ulcerative colitis.

Reference materials:https://go.drugbank.com/drugs/DB14910