Lilly has announced that its interleukin-23 blocker mirikizumab demonstrated promise in patients with moderately to severely active ulcerative colitis (UC) in the ongoing open-label LUCENT-3 extension study. The trial evaluated two-year efficacy and safety of the monoclonal antibody in patients who had previously undergone UC treatments, including biologics, that were ineffective, stopped working, or were intolerable.
In April, the company announced that it had received a complete response letter for mirikizumab for UC as a result of issues FDA identified related to the proposed manufacturing of the antibody. The agency noted no concerns about the clinical data package, safety, or label for the therapy.
After revealing the most recent LUCENT-3 data, Lilly plans on filing a marketing application for mirikizumab in Crohn’s disease to FDA. It intends to file paperwork with other regulatory agencies in 2024.
Mirikizumab efficacy in LUCENT-3The LUCEN…