The status of the launch of Mirikizumab

Mirikizumab is a new monoclonal antibody drug developed by Eli Lilly (Eli Lilly), specifically used to treat ulcerative colitis. This drug effectively interferes with the activity of pro-inflammatory cytokines by inhibiting the function of interleukin-23 (IL-23), thereby reducing the related inflammatory response. This mechanism has important clinical application value.

So far, Milizumab has received marketing approval in multiple countries. First, the drug was the first to receive marketing approval in Japan. Subsequently, in May 2023, the European Medicines Agency (EMA) officially approved its marketing; in July of the same year, Canada also granted permission for the use of the drug. Finally, in October 2023, militizumab was approved 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. Despite this, as of February 2025, militizumab has not yet entered the Chinese market.

MilizumabFDA approval came from a clinical study called "LUCENT." This study includes two randomized, double-blind, placebo-controlled phase III clinical trials, namely UC-1 and UC-2. UC-1 is a 12-week induction study and UC-2 is a 40-week maintenance study, with a total treatment process of 52 weeks. Study results showed that after 12 weeks of Omvoh treatment, approximately 65% u200bu200bof patients in the placebo group achieved clinical remission, and nearly a quarter (24%) of patients achieved complete clinical remission. Specific data show that the clinical remission rate and complete clinical remission rate of the drug are 43% and 15% respectively, which further illustrates the significant effect of militizumab in improving the patient's condition and brings new treatment hope to the majority of patients with ulcerative colitis.

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