FDA Approves Simplified Single-Injection Maintenance Regimen for Lilly's Omvoh in Ulcerative Colitis
核心洞察
The FDA has approved a single-injection, once-monthly maintenance regimen for Omvoh (mirikizumab-mrkz (搜索)) in adults with moderately to severely active ulcerative colitis (搜索), replacing the previous two-injection regimen.
The approval is based on a Phase 1 bioequivalence study demonstrating that one 200 mg/2 mL subcutaneous injection delivers the same proven results as two 100 mg/1 mL injections.
The simplified dosing regimen will be available in the U.S. via prefilled pen or prefilled syringe in early 2026, following recent European Union authorization for the same indication.
Eli Lilly and Company announced that the U.S. Food and Drug Administration has approved a single-injection, once-monthly maintenance regimen (200 mg/2 mL) of Omvoh (mirikizumab-mrkz (搜索)) for subcutaneous use in adults with moderately to severely active ulcerative colitis (搜索). The approval simplifies treatment by replacing the previous two-injection maintenance regimen with a single monthly injection.
Streamlined Treatment Experience
"In clinical practice, we see that simplifying maintenance treatment can make a difference in the overall patient experience," said Miguel Regueiro, M.D., board-certified gastroenterologist specializing in inflammatory bowel disease (搜索). "A single monthly injection of Omvoh gives patients a regimen that's easier to manage alongside the unpredictability of living with ulcerative colitis (搜索)."
The single-injection, citrate-free maintenance dose will be available in the U.S. via prefilled pen or prefilled syringe in early 2026. The U.S. approval follows the recent European Union authorization of Omvoh for single-injection maintenance dosing for ulcerative colitis (搜索).
Clinical Evidence Supporting Approval
The single-injection approval is based on results from a Phase 1 study comparing one 200 mg/2 mL subcutaneous injection to two 100 mg/1 mL injections in participants. The study confirmed that Omvoh single-injection is bioequivalent to the previously approved two-injection regimen.
"People living with the constant discomfort and disruption caused by the symptoms of ulcerative colitis (搜索) need treatments that offer the potential to achieve lasting remission and a convenient dosing option that fits easily into their lives," said George Salem, M.D., director of Crohn's and Colitis Center at OU HEALTH. "With this approval, patients who respond to induction therapy with Omvoh can continue maintenance therapy with the convenience of just one injection each month — delivering the same proven results with fewer injections."
Treatment Protocol and Mechanism
Treatment with Omvoh for ulcerative colitis (搜索) starts with 300-mg IV infusions every four weeks, for a total of three infusions, and at Week 12 transitions to subcutaneous self-injection every four weeks for maintenance treatment. Omvoh (mirikizumab-mrkz (搜索)) is an interleukin-23p19 (搜索) (IL-23p19) antagonist that selectively targets the p19 subunit of IL-23 (搜索) and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of inflammatory bowel disease (搜索).
Expanding Treatment Portfolio
"At Lilly, we are committed to supporting people living with IBD by delivering meaningful clinical outcomes and continuing to improve their treatment experience," said Ashley Diaz-Granados, senior vice president of U.S. Immunology at Lilly. "Building on the introduction of a citrate-free formulation of Omvoh earlier this year, this approval further delivers on our commitment by providing patients the same outcomes in a single-injection maintenance regimen that fits more seamlessly into their lives."
This marks the third FDA approval for Omvoh in 2025, following approvals for Crohn's disease (搜索) and a citrate-free formulation. Omvoh is approved in the U.S. for the treatment of moderately to severely active ulcerative colitis (搜索) and moderately to severely active Crohn's disease in adults and has been approved in 45 countries around the world.
Safety Profile and Patient Support
The most common side effects of Omvoh in people treated for ulcerative colitis (搜索) include upper respiratory infections, injection site reactions, joint pain, rash, headache, and herpes viral infections. Omvoh may cause serious side effects including serious allergic reactions, infections, and liver problems, requiring careful monitoring by healthcare providers.
Through Lilly Support Services, Lilly offers a patient support program including co-pay assistance for eligible, commercially insured patients. The company continues to focus on making treatments more accessible and convenient for patients managing inflammatory bowel disease (搜索).