Mirikizumab
- Generic Name
- Mirikizumab
- Brand Names
- Omvoh
- Drug Type
- Biotech
- 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
Anti-IL23p19 Therapies Transform IBD Treatment Landscape Ahead of ECCO 2025
• The anti-IL23p19 class has emerged as a breakthrough in IBD treatment, with three major players - AbbVie's Skyrizi, Eli Lilly's Omvoh, and J&J's Tremfya - reshaping the therapeutic landscape.
• ECCO 2025 will showcase critical data for these therapies, including Omvoh's long-term efficacy in Crohn's disease, Tremfya's subcutaneous induction results, and new bowel urgency endpoints for ulcerative colitis.
• Market dynamics are evolving with the entry of Stelara biosimilars in Europe and the emergence of new therapeutic approaches, including TL1A inhibitors and IL-7R antagonists.
Eli Lilly Reports Doubled Q4 Profits Driven by Surging Obesity and Diabetes Drug Sales
• Eli Lilly's Q4 net income soared to $4.4 billion, doubling from $2.2 billion year-over-year, propelled by strong performance of Mounjaro and Zepbound in the diabetes and obesity markets.
• Mounjaro sales surged 60% to $3.5 billion in Q4, while the newly launched Zepbound generated $1.9 billion in revenue, marking significant growth in the incretin drug market.
• The company projects 2025 non-GAAP earnings of $22.50-$24.00 per share and plans to increase incretin drug production capacity by at least 60% in the first half of 2025.
FDA Approvals and Clinical Trials Signal Growth for Eli Lilly
Eli Lilly has recently gained FDA approval for Omvoh, a treatment for Crohn's disease, and Kisunla, aimed at early-stage Alzheimer's patients. These approvals, based on promising clinical trial results, are expected to significantly contribute to the company's growth, with Omvoh potentially reaching over $2 billion in annual sales and Kisunla expected to exceed $7 billion.
FDA Approvals and Clinical Trials: A Look into the Latest Pharmaceutical Developments
The pharmaceutical sector has seen significant advancements with FDA approvals for new treatments and the initiation of clinical trials for innovative therapies. Notably, Eli Lilly's Omvoh has been approved for Crohn's disease, and Johnson & Johnson is advancing its TAR-200 for bladder cancer treatment. These developments underscore the industry's commitment to addressing unmet medical needs through research and innovation.
FDA Approves Lilly's Omvoh (mirikizumab) for Crohn's Disease
• The FDA has approved Eli Lilly's Omvoh (mirikizumab-mrkz) for treating moderately to severely active Crohn's disease in adults, expanding its use for inflammatory bowel disease.
• The approval was based on the VIVID-1 trial, which showed significant clinical remission and endoscopic response rates compared to placebo after one year of treatment.
• Omvoh is the first biologic in over 15 years with Phase 3 two-year efficacy data at launch, demonstrating long-term disease control and visible healing of the intestinal lining.
• Lilly has submitted marketing applications globally, aiming to provide a new treatment option for Crohn's patients and is working with insurers to enable patient access.
GI Advances: FDA Approvals, Novel Research Shape Gastroenterology in Early 2025
• The FDA approved mirikizumab (Omvoh) for Crohn's disease, marking its second approval in IBD after ulcerative colitis, based on positive Phase 3 trial results.
• A tentative FDA approval was granted for a generic version of rifaximin for IBS-D, offering a potential cost-effective alternative pending the resolution of ongoing litigation.
• Ironwood initiated a rolling NDA submission for apraglutide, aiming to address short bowel syndrome by reducing dependence on parenteral support.
• Research indicates fecal microbiota transplantation (FMT) shows promise in treating type 1 diabetes and gastroenteropathy, improving patient quality of life.
Lilly's Omvoh Nears EU Approval for Crohn's Disease After Positive CHMP Opinion
• The European Medicines Agency's CHMP recommended Omvoh (mirikizumab) for adults with moderately to severely active Crohn's disease.
• The recommendation is based on the Phase 3 VIVID-1 trial, which showed significant improvements in clinical remission and endoscopic response.
• Omvoh could become the first Crohn's treatment with improvements in histologic measures of inflammation on its label.
• Regulatory decisions in the U.S. and Japan are expected in the first half of 2025, expanding Omvoh's potential global reach.
Eli Lilly's Zepbound Demonstrates Superior Weight Loss Compared to Novo Nordisk's Wegovy in Head-to-Head Trial
• Eli Lilly's Zepbound (tirzepatide) led to a 20.2% average weight loss, significantly outperforming Wegovy (semaglutide) at 13.7% in a 72-week clinical trial.
• The SURMOUNT-5 trial included overweight or obese adults without diabetes, showing Zepbound users experienced 47% more relative weight loss than Wegovy users.
• Zepbound, a dual GIP and GLP-1 receptor agonist, helped 31.6% of participants achieve at least 25% body weight loss, compared to 16.1% with Wegovy.
• The study's findings may influence treatment choices, with Zepbound potentially becoming a preferred option for greater weight loss outcomes, pending further data on tolerability.
Johnson & Johnson Seeks FDA Approval for Tremfya to Treat Pediatric Psoriasis and Arthritis
• Johnson & Johnson has submitted sBLAs to the FDA for Tremfya (guselkumab) to treat moderate-to-severe plaque psoriasis in children aged 6 and older.
• The submission also seeks approval for Tremfya to treat active juvenile psoriatic arthritis in children aged 5 and older.
• The sBLAs are based on data from the Phase 3 PROTOSTAR study and pharmacokinetic data from adult studies VOYAGE 1 and 2, and DISCOVER 1 and 2.
• Tremfya, an IL-23 inhibitor, is already approved for adults with plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
Drug Development Updates
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