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
- -
Lilly's Omvoh® (mirikizumab) recommended by CHMP for approval in the European Union
The EMA's CHMP issued a positive opinion for Omvoh® (mirikizumab) for treating adults with moderately to severely active Crohn’s disease. Omvoh, an IL-23p19 antagonist, showed significant improvements in clinical remission, endoscopic response, and bowel urgency in the Phase 3 VIVID-1 trial. If approved, it would be the first treatment for Crohn’s disease with histologic measures of inflammation in its label. Regulatory decisions for Omvoh in the U.S. and Japan are expected in early 2025.
Eli Lilly's Omvoh Scores Landmark CHMP Backing for Crohn's Disease, First to Show ...
The EMA's CHMP issued a positive opinion for Omvoh (mirikizumab) for treating moderately to severely active Crohn's disease. Omvoh, an IL-23p19 antagonist, showed significant improvements in endoscopic and clinical remission, bowel urgency, and histologic inflammation in the Phase 3 VIVID-1 trial. Regulatory decisions for Omvoh in the U.S. and Japan are expected in 2025.
Eli Lilly's Omvoh nears EU approval for Crohn's disease
Eli Lilly announced CHMP's recommendation for Omvoh (mirikizumab) approval for Crohn's disease, based on Phase 3 VIVID-1 trial results. Omvoh could be the first treatment to include histologic inflammation improvements. Lilly also highlighted in obesity drug market with GLP-1 medications and reported promising Phase 3 EMBER-3 study results for imlunestrant in advanced breast cancer.
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J&J Seeks FDA Approval for Tremfya for Psoriasis in Kids
Johnson & Johnson filed two sBLAs for Tremfya, seeking expanded use in pediatric patients with moderate-to-severe plaque psoriasis and active juvenile psoriatic arthritis. Tremfya, an IL-23 inhibitor, is already approved for adult patients with psoriasis and psoriatic arthritis. The filings are based on phase III studies and PK data. Tremfya sales grew 21.6% year-over-year to $2.7 billion in the first nine months of 2024. J&J expects Tremfya to reach $5 billion with approvals for inflammatory bowel disease conditions.
Eli Lilly Shares Positive Phase III Data of Mirikizumab for the Treatment of Crohn's Disease
Eli Lilly's mirikizumab showed sustained remission in UC and Crohn's disease, approved by FDA as Omvoh for UC. Johnson & Johnson's Tremfya demonstrated robust results in Crohn's disease with a subcutaneous regimen.
J&J and Lilly both boast IL-23 inhibitor efficacy in Crohn's disease
J&J and Eli Lilly revealed efficacy of their IL-23 inhibitors, Tremfya and Omvoh, in treating Crohn’s disease, with both drugs showing significant clinical and endoscopic remission rates in Phase III trials. Both companies aim for FDA approval, with Tremfya already approved for UC, plaque psoriasis, and psoriatic arthritis, while Omvoh is superior to Stelara in treating Crohn's disease. GlobalData predicts Tremfya sales to reach $8.4bn by 2030, surpassing Omvoh's projected $867m.
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J&J and Lilly both unveil IL-23 inhibitor efficacy in Crohn's disease
J&J and Eli Lilly revealed efficacy data for their IL-23 inhibitors, Tremfya and Omvoh, in treating Crohn’s disease, with both drugs aiming for FDA approval. Tremfya showed 60-66.1% clinical remission rates at 48 weeks, while Omvoh achieved 81% clinical and 82% endoscopic remission after two years. GlobalData forecasts Tremfya sales to reach $8.4bn by 2030, surpassing Omvoh's projected $867m.
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Lilly and J&J Face Off in Crohn's Disease With Phase III Readouts at ACG 2024
Eli Lilly’s Omvoh and Johnson & Johnson’s Tremfya showed strong remission and response rates in Crohn’s disease patients, according to Phase III data presented at the 2024 American College of Gastroenterology Annual Scientific Meeting. Tremfya demonstrated 60-66.1% clinical remission rates at 48 weeks, while Omvoh achieved 87% clinical remission and 54% endoscopic remission in long-term Crohn’s disease patients. Both companies seek to expand their treatments into Crohn’s disease.
Omvoh Achieves Long-Term Remission, Symptom Improvement for Ulcerative Colitis, Crohn
Eli Lilly's Omvoh (mirikizumab) demonstrated stable, long-term remission and improved symptoms in UC and CD patients, with consistent safety profiles. Omvoh, an IL23p19 antagonist, selectively targets the p19 subunit of IL-23, and is the first of its kind approved for UC treatment. Multi-year trials showed sustained benefits across various endpoints and no new safety signals.
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