On 15 January 2025, Eli Lilly announced that the US FDA has approved Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease in adults. This follows FDA approval of Omvoh® for ulcerative colitis in October 2023.
In August 2024, Omvoh® was listed for evaluation by Australia’s Therapeutic Goods Administration (TGA) for the treatment of ulcerative colitis. In December 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended an indication expansion of Omvoh® for moderately to severely active Crohn’s disease.