Lilly Plans Mirikizumab Filing For Crohn’s After Phase III Success

 
• By Joseph Haas
  
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Mirikizumab, already under review at the FDA for ulcerative colitis, bests placebo on two primary endpoints in Crohn’s. Lilly hopes to beat AbbVie’s Skyrizi, already approved for Crohn's, to market in UC.

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Lilly intends to go head-to-head with AbbVie's Skyrizi in IBD

Eli Lilly and Company’s ambitions for mirikizumab to compete with AbbVie Inc.’s Skyrizi (risankizumab) in the inflammatory bowel disease space appear to be progressing with the recent re-filing of a biologic licensing application for ulcerative colitis and Phase III data reported on 12 October that shows Lilly’s IL-23 antagonist meeting statistical significance for both clinical remission and endoscopic response in Crohn’s disease.

Key Takeaways

  • Lilly hit both co-primary endpoints in a Phase III trial of IL-23 antagonist mirikizumab in Crohn’s disease.

Skyrizi – which like mirikizumab binds to the p19 subunit of interleukin-23, a pathway over-activated in both UC and Crohn’s...

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