Mirikizumab

Mirikizumab is a monoclonal antibody developed by Eli Lilly intended to treat ulcerative colitis. It inhibits the actions of interleukin-23 (IL-23), a pro-inflammatory cytokine that activates pathways contributing to the development of inflammatory diseases.

Mirikizumab is approved in Japan and received a positive opinion from the EMA's Committee for Medicinal Products for Human Use in March 2023. In April 2023, the US FDA declined to approve mirikizumab for the treatment of ulcerative colitis on the basis of manufacturing concerns. It was officially approved in the EU in May 2023 and Canada in July 2023, and was eventually approved in the US in October 2023 for the treatment of adult patients with moderate-to-severely active ulcerative colitis.