pharmaphorum.com
Lilly nets a second FDA okay for Omvoh, in Crohn's disease
A new FDA approval means another IL-23 option is formally available for people with moderately to severely active Crohn’s disease, including patients whose disease did not respond to other therapies. This could affect treatment choices and insurance coverage discussions.
Adults with Crohn’s disease, especially those who have failed other biologics or immunosuppressants; clinicians who treat IBD; patients currently on or considering IL-23 therapies; IBD researchers and policy/market watchers.
What To Know
Lilly’s Omvoh (mirikizumab), an IL-23 inhibitor already approved for ulcerative colitis, received FDA approval for moderately to severely active Crohn’s disease based on the VIVID-1 trial and supporting VIVID-2 extension data.
The article summarizes trial remission and endoscopic response numbers and positions Omvoh within the competitive IL-23 class alongside Skyrizi (risankizumab), Stelara (ustekinumab), Tremfya (guselkumab) and Ilumya (tildrakizumab). It also notes the drug’s prior UC approvals, ongoing submissions in other regions, and commercial context and projections.
This is a regulatory approval news item based on clinical trial results (VIVID program) reported in the article. The piece includes commercial analysis and comparisons with other IL-23 drugs; it does not provide prescribing guidance.
Real-world availability, formulary coverage, and how Omvoh compares clinically to other approved options will depend on regulatory labels, guideline updates, and payer decisions.
