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Does Lilly plan to submit mirikizumab for regulatory approval for ulcerative colitis?
Lilly plans to submit a Biologics License Application (BLA) to the FDA for mirikizumab for the treatment of ulcerative colitis, followed by submissions to other regulatory agencies around the world in the first half of 2022.
Phase 3 Data Supporting Regulatory Submission
In December 2021, topline results of the phase 3 maintenance study of mirikizumab for the treatment of ulcerative colitis, LUCENT-2, were announced. Mirikizumab met the primary endpoint of clinical remission and all key secondary endpoints. Additional data will be disclosed at future congresses and publications in 2022.1
1Mirikizumab demonstrates superiority over placebo in phase 3 maintenance study in ulcerative colitis, supporting regulatory submissions in 2022. Press release. Eli Lilly and Company; December 14, 2021. Accessed December 15, 2021. https://investor.lilly.com/news-releases/news-release-details/mirikizumab-demonstrates-superiority-over-placebo-phase-3
Date of Last Review: December 15, 2021