Eli Lilly’s Omvoh (mirikizumab-mrkz) Receives the US FDA’s Approval for Ulcerative Colitis
Shots:
- The US FDA has approved Omvoh (200mg/2mL, SC, QM) as a maintenance treatment of adults with mod. to sev. active ulcerative colitis; PFS & prefilled pen to be available in early 2026
- Approval was based on P-I trial assessing Omvoh (200mg/2mL, SC) single injection vs 2 100mg/1mL injections in participants, which showed bioequivalence between the two
- Omvoh, an IL-23p19 antagonist, is initiated with 300mg IV (Q4W) for three doses, followed by 200mg SC (Q4W) starting at Wk. 12 for maintenance in ulcerative colitis
Ref: Eli Lilly | Image: Eli Lilly| Press Release
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