Eli Lilly's IL-23 Monoclonal Antibody Mirikizumab Designated for Breakthrough Therapy in Crohn’s Disease

On July 24, the CDE website showed that Eli Lilly's investigational IL-23p19 monoclonal antibody mirikizumab is proposed for inclusion in the breakthrough therapy designation for the treatment of adult patients with moderate to severe active Crohn's disease (CD).

Mirikizumab is a monoclonal antibody targeting the IL-23p19 subunit, currently under development for indications including ulcerative colitis, Crohn's disease, and plaque psoriasis. On March 27, 2023, the drug was approved for the first time by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of ulcerative colitis.

However, the road to Mirikizumab's market entry in the United States has not been smooth. On April 13, 2023, Eli Lilly received a Complete Response Letter from the FDA regarding the Biologics License Application for mirikizumab for the treatment of ulcerative colitis (UC). The FDA indicated concerns about the manufacturing process of Mirikizumab but acknowledged the clinical data, safety, and labeling. Eli Lilly expressed confidence in the pivotal Phase III clinical data of mirikizumab and its potential to treat ulcerative colitis, and stated that it will continue to actively collaborate with the FDA to facilitate the completion of Mirikizumab’s U.S. market entry as soon as possible.

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