Mirikizumab
- Generic Name
- Mirikizumab
- Brand Names
- Omvoh
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1884201-71-1
- Unique Ingredient Identifier
- Z7HVY03PHP
- Background
Mirikizumab is a monoclonal antibody developed by Eli Lilly intended to treat ulcerative colitis. It inhibits the actions of interleukin-23 (IL-23), a pro-inflammatory cytokine that activates pathways contributing to the development of inflammatory diseases.
Mirikizumab is approved in Japan and received a positive opinion from the EMA's Committee for Medicinal Products for Human Use in March 2023. In April 2023, the US FDA declined to approve mirikizumab for the treatment of ulcerative colitis on the basis of manufacturing concerns. It was officially approved in the EU in May 2023 and Canada in July 2023, and was eventually approved in the US in October 2023 for the treatment of adult patients with moderate-to-severely active ulcerative colitis.
- Indication
Mirikizumab is indicated for the treatment of adult patients with moderate-to-severely active ulcerative colitis.
- Associated Conditions
- Moderately to Severely Active Ulcerative Colitis
- Associated Therapies
- -
Eli Lilly's Omvoh bests J&J's Stelara in late-stage study for Crohn's
Eli Lilly’s Omvoh outperforms J&J’s Stelara in late-stage Crohn’s study; EU medtech market sees innovation.
Lilly touts Omvoh's superiority over J&J's Stelara in Crohn's
Eli Lilly's Omvoh (mirikizumab) showed superior histological results in Phase III VIVID-1 trial for Crohn’s disease compared to Johnson & Johnson’s Stelara. Omvoh, approved for ulcerative colitis, faces competition from Humira and Stelara. Lilly filed for Omvoh approval in Crohn’s disease globally.
Related Clinical Trials:
Lilly's Omvoh Beats J&J's Stelara in Head-to-Head Phase III Crohn's Disease Trial
Eli Lilly's Omvoh showed better histologic response vs. J&J's Stelara in Crohn's disease patients after 52 weeks, with safety consistent with known profile. Lilly aims to expand Omvoh's label and therapeutic potential in inflammatory bowel diseases, potentially challenging Stelara's market dominance.
Lilly reports one-year histologic outcomes in Phase 3 study of mirikizumab compared to ...
Eli Lilly announced data showing more Crohn’s disease patients treated with mirikizumab achieved histologic response at Week 52 compared to ustekinumab, regardless of prior biologic experience. Mirikizumab, an IL23p19 antagonist, selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor, potentially providing greater depth of mucosal healing.
Related Clinical Trials:
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Exciting Advances in Ulcerative Colitis Treatments: Skyrizi
The UC market saw significant advancements with FDA approvals for AbbVie's Skyrizi and Johnson & Johnson's Tremfya. A Spherix survey revealed Skyrizi's rapid adoption and positive efficacy perceptions, capturing double the market share of Omvoh. Skyrizi's on-body injector received moderate to high satisfaction. With three IL-23 inhibitors now available, Spherix will monitor market dynamics to identify the preferred treatment.
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The drug and biotech sector has outperformed the broader market, driven by new drug launches, pipeline successes, and increased M&A activity. Eli Lilly's obesity drugs have been particularly successful. Despite headwinds like pipeline setbacks and economic uncertainty, the sector has seen a surge in investments. Five large drugmakers—Pfizer, Eli Lilly, AstraZeneca, Bayer, and Sanofi—are recommended for portfolio growth, with strong financials and robust pipelines.
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Drug Development Updates
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