By Colin Kellaher
Eli Lilly on Thursday said a Phase 3 study of its investigational drug mirikizumab met the co-primary and all major secondary endpoints in the treatment of adults with moderately to severely active Crohn’s disease.
The Indianapolis drugmaker said mirikizumab showed clinical remission and endoscopic response through 52 weeks, adding that the study will be the basis of global regulatory submissions for mirikizumab in the inflammatory bowel disorder.
Eli Lilly said it plans to file next year for U.S. Food and Drug Administration approval of mirikizumab, followed by submissions to other regulatory agencies around the world.
The FDA earlier this year turned away Eli Lilly’s application seeking approval of mirikizumab in ulcerative colitis, citing issues related to the proposed manufacturing of the drug.
Mirikizumab, marketed as Omvoh, is approved for the treatment of moderately to severely active ulcerative colitis in Japan, Germany, the U.K. and Canada.
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