Eli Lilly's Omvoh Bags FDA Nod to treat Crohn's disease in Adults

Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has authorized Omvoh (mirikizumab-mrkz) for treating moderately to severely active Crohn's disease in adults. Omvoh has received approval in the US for two forms of inflammatory bowel disease (IBD), after its October 2023 authorization as a first-in-class solution for moderately to severely active ulcerative colitis (UC) in adults.

Omvoh aims to decrease inflammation in the gastrointestinal tract by focusing on a particular protein, interleukin-23p19 (IL-23p19), which plays a crucial role in causing intestinal inflammation. Omvoh is the first biologic therapy in over 15 years to have revealed two-year phase 3 efficacy results in Crohn's disease upon its approval.

"The burden of Crohn's disease on patients' daily lives is substantial," said Michael Osso, president and chief executive officer, Crohn's & Colitis Foundation. "This approval is meaningful for adult patients with Crohn's disease, who now have more treatment options available."

This endorsement is founded on favorable outcomes from the phase 3 VIVID-1 clinical trial of Omvoh in adults suffering from moderately to severely active Crohn's disease who experienced an insufficient response, loss of response, or intolerance to corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, and methotrexate), and/or biologics (TNF inhibitors, integrin receptor blockers).1 VIVID-1 was a randomized, placebo-controlled study of Omvoh. Patients assigned to placebo who did not reach a clinical response through patient-reported outcomes at 12 weeks (40% of patients on placebo) were later transitioned to Omvoh treatment. The two main endpoints in VIVID-1 were accomplished: