Lilly's Omvoh (mirikizumab-mrkz) approved by U.S. FDA as a single-injection maintenance regimen in adults with ulcerative colitis

Core Insights - Eli Lilly and Company announced FDA approval for a single-injection, once-monthly maintenance regimen of Omvoh (mirikizumab-mrkz) for adults with moderately to severely active ulcerative colitis, set to be available in early 2026 [1][2][4] Product Details - Omvoh's single-injection dosing replaces the previous two-injection regimen, simplifying the maintenance experience for patients [1][2] - The new formulation is citrate-free and will be available via prefilled pen or syringe [2] - Omvoh is already approved for Crohn's disease and has received three FDA approvals in 2025 [1][4] Clinical Significance - The approval is based on a Phase 1 study demonstrating that the single-injection is bioequivalent to the two-injection regimen, confirming its efficacy [3] - The treatment protocol begins with 300 mg IV infusions every four weeks for three infusions, transitioning to subcutaneous self-injection every four weeks for maintenance [3][15] Market Position - Omvoh is approved in the U.S. for both ulcerative colitis and Crohn's disease, with approvals in 45 countries globally [4][20] - Eli Lilly emphasizes its commitment to improving treatment experiences for patients with inflammatory bowel disease (IBD) [4][21]