Lilly and J&J Unveil Promising IL-23 Inhibitor Data for Crohn’s Disease, Setting Stage for FDA Decisions

Clinical Trial Results:

Eli Lilly’s Omvoh (mirikizumab):
Long-term results showed 87% of patients reached clinical remission, 76% showed endoscopic response, and 54% were in endoscopic remission.

Johnson & Johnson’s Tremfya (guselkumab):
56.1% of patients achieved clinical remission at 12 weeks, and 60% and 66.1% achieved clinical remission at 48 weeks with different dosing regimens.

Regulatory Submissions:

Both Lilly and J&J have submitted applications for label expansions for their respective drugs in Crohn’s disease, following approvals for ulcerative colitis.

Market Potential:

GlobalData projects Tremfya’s global sales to reach $7.8 billion by 2029, highlighting its potential to set a new standard in Crohn’s disease treatment.

Competitive Landscape:

Tremfya and Omvoh are positioned to compete with AbbVie’s Skyrizi, which already has approvals for both Crohn’s disease and ulcerative colitis.

Patient Convenience:

Tremfya offers a fully subcutaneous regimen, providing patients with a more convenient option for self-administration from the start of treatment.