FDA OKs single-injection Omvoh maintenance regimen for ulcerative colitis

On October 27, 2025, FDA approved a single-injection, once-monthly maintenance regimen (200 mg/2 mL) of Omvoh (mirikizumab-mrkz) for SC use in adults with moderately to severely active ulcerative colitis (UC).

The single-injection approval is based on results from a Phase 1 study comparing one 200 mg/2 mL SC 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. Treatment with Omvoh for ulcerative colitis starts with 300-mg IV infusions every four weeks, for a total of three infusions, and at Week 12 transitions to SC self-injection every four weeks for maintenance treatment.

According to a manufacturer press release, the single-injection, citrate-free maintenance dose will be available in the U.S. via prefilled pen or prefilled syringe in early 2026.

Sources:

Omvoh (mirikizumab-mrkz) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761279s005lbl.pdf Revised October 2025. Accessed October 31, 2025.

Lilly’s Omvoh (mirikizumab-mrkz) approved by US FDA as a single-injection maintenance regimen in adults with ulcerative colitis. [News release]. 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-omvoh-mirikizumab-mrkz-approved-us-fda-single-injection