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FDA Approves Mirikizumab (Omvoh) for Ulcerative Colitis

Eli Lilly and Company announced the FDA approval of mirikizumab (Omvoh) for moderately and severely active ulcerative colitis in adults on October 26, 2023. ....

Patrik Jonsson , Burrillb Crohn , Eli Lilly , Pbruce Sands , Henryd Janowitz Division Of Gastroenterology , Icahn School Of Medicine At Mount Sinai , Drug Administration Issues Complete Response Letter , Drug Administration , Colitis Foundation , Icahn School , Biologics License Application , Complete Response Letter , Urgency Numeric Rating Scale , Michael Osso , Lilly Immunology , Lilly United States , Mirikuzmab Omvoh , Mirikizumab And Uc , Ulcerative Colitis ,

Mirikizumab Bests Placebo in Treating Patients With Ulcerative Colitis

There were higher percentages of patients treated with mirikizumab that had clinical remission at week 12 of the induction trial compared to the placebo group. This was also true at week 40 of the maintenance trial. ....

Geert Dhaens , Eli Lilly , Drug Administration Issues Complete Response Letter , Geertd Haens , Retrieved April ,

FDA Issues Response Letter for Mirikizumab

The FDA cited manufacturing concerns in their letter for the potential ulcerative colitis treatment. ....

Eli Lilly , Patrik Jonsson , Colitis Organization , Drug Administration , Drug Administration Issues Complete Response Letter , Complete Response Letter , Biologic License Application , Lilly Immunology , Lilly United States , European Crohn , Retrieved April ,