Omvoh(mirikizumab)

Omvoh (mirikizumab) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy, or a biologic treatment or a Janus kinase (JAK) inhibitor, or have medical contraindications to such therapies. The application for Omvoh was a Standard resubmission BLA (Application Number 761279) submitted on May 24, 2023, with a Review Completion Date of October 26, 2023.

In a Phase 3, multicenter, randomized, double-blind, parallel group, placebo-controlled induction trial (Study I6T-MC-AMAN) lasting 12 weeks, Omvoh demonstrated superior clinical remission compared to placebo. At Week 12, clinical remission was 23.5% for Omvoh, compared to 13.9% for placebo, showing a treatment difference of 9.9%. An alternate clinical remission endpoint at Week 12 showed 24.0% for Omvoh versus 14.6% for placebo, with a treatment difference of 9.7%.

Safety findings include 145 subjects with an infection. The NOAEL (No Observed Adverse Effect Level) for developmental effects of Mirikizumab was 300 mg/kg, with a safety margin for the proposed maximum human dose of 8-fold. The maternal and developmental NOAELs were both 300 mg/kg/dose. The historical control range for combined fetal/infant losses was 20 to 42.9%.