Mirikizumab

Topline findings from the phase 3 VIVID-1 trial showed Eli Lilly’s mirikizumab, an interleukin-23p19 antagonist, demonstrated clinical remission and endoscopic response through 52 weeks in adults with moderate to severe Crohn’s disease.

In two phase 3 trials, mirikizumab induced and maintained remission at a higher rate compared with placebo among patients with moderate to severely active ulcerative colitis, according to data in The New England Journal of Medicine.

The FDA issued a complete response letter to Eli Lilly indicating it cannot approve the company’s biologic license application seeking approval for mirikizumab as a treatment for ulcerative colitis.