Introduction to Mirikizumab-mrkz
Mirikizumab-mrkz, marketed as Omvoh®, is a groundbreaking IL23p19 antagonist developed by Eli Lilly and Company. It has made significant strides in the treatment of moderately to severely active ulcerative colitis (UC) and Crohn's disease, offering long-term sustained efficacy and safety data that set it apart from other treatments in its class.
Clinical Efficacy and Safety
Long-Term Efficacy in Ulcerative Colitis
Mirikizumab has demonstrated impressive long-term outcomes in patients with UC. In the LUCENT-3 study, over 80% of patients who achieved clinical remission with mirikizumab at one year maintained long-term clinical remission for up to three years. Additionally, 82% achieved long-term endoscopic remission, and 72% had mucosal healing. These results indicate a sustained benefit across symptomatic, clinical, endoscopic, and histologic endpoints, even in patients who had previously failed other biologics or treatments like TNF inhibitors and tofacitinib[1][5].
Long-Term Efficacy in Crohn's Disease
For Crohn's disease, mirikizumab has shown equally promising results. In the VIVID-2 long-term extension study, patients treated with mirikizumab maintained high rates of clinical and endoscopic remission over five years. Specifically, 96% of patients had a clinical response, 87% were in clinical remission, and 54% achieved endoscopic remission[1][5].
Safety Profile
The safety profile of mirikizumab is consistent with its known adverse event profile. In the LUCENT-3 study for UC, 7.4% of patients reported serious adverse events, and 5.3% discontinued treatment due to adverse events. For Crohn's disease, 8.5% reported serious adverse events, and 1.9% discontinued treatment due to adverse events in the VIVID-2 study[1][5].
Market Impact and Financial Trajectory
Market Positioning
Mirikizumab is the first and only IL23p19 antagonist to report multi-year, long-term sustained efficacy data in both UC and Crohn's disease. This unique positioning gives it a competitive edge in the market, particularly as it addresses difficult-to-manage symptoms and provides lasting results over time[1][5].
Budget Impact Analysis
A budget impact analysis suggests that introducing mirikizumab to formulary for moderately to severely active UC may be relatively budget-neutral or even cost-saving. The analysis estimated that the cumulative incremental costs over three years would be minimal, around $1.3 million, which translates to $0.04 per member per month (PMPM) or $0.43 per member per year (PMPY). If mirikizumab's market share were to come solely from ustekinumab, the model predicted total cost savings of $2.6 million over three years[2].
Global Regulatory Submissions and Approvals
Omvoh® was approved by the FDA in October 2023 for the treatment of moderately to severely active UC in adults and is also approved in 44 countries worldwide. Lilly has submitted marketing authorization applications for mirikizumab in Crohn's disease globally, including in the U.S., Canada, Europe, Japan, and China, with additional regulatory submissions planned[1][4].
Market Dynamics in the Biologics Sector
Growing Share of Biologics
Biologics, including mirikizumab, are increasingly dominant in the pharmaceutical market. They now represent 42% of the total medicines market, up from 30% in 2014. This growth is driven by their effectiveness in treating complex diseases like inflammatory bowel diseases (IBD)[3].
Competition and Biosimilars
The biologics market is evolving with the emergence of biosimilars, which could impact the market dynamics. However, mirikizumab's unique mechanism of action and long-term efficacy data position it strongly against potential biosimilar competition. As of now, there are no biosimilars approved for mirikizumab, giving it a significant market advantage[3].
Financial Projections and Spending Trends
Net Spending on Biologics
The net spending on biologics has increased by 50% since 2014 on a real net per capita basis, while small molecules have declined by 12%. This trend indicates a growing financial investment in biologic therapies, which bodes well for the financial trajectory of mirikizumab[3].
Patient Population and Eligibility
The budget impact analysis suggests that the introduction of mirikizumab could manage a significant patient population. For example, in the base case, 445 to 515 patients per year were predicted to be eligible for advanced therapies for UC, with total UC drug management expenditures of $137.4 million over three years[2].
Conclusion
Mirikizumab-mrkz is poised to make a significant impact in the treatment of UC and Crohn's disease, driven by its long-term efficacy and safety profile. Its unique market positioning, minimal budget impact, and growing demand for biologic therapies suggest a strong financial trajectory.
Key Takeaways
- Long-Term Efficacy: Mirikizumab has demonstrated sustained efficacy in both UC and Crohn's disease over multiple years.
- Safety Profile: The drug has a consistent safety profile with manageable adverse event rates.
- Market Positioning: It is the first IL23p19 antagonist with long-term data, giving it a competitive edge.
- Budget Impact: Introduction to formulary is expected to be budget-neutral or cost-saving.
- Global Approvals: Approved in 44 countries and pending approvals in several others.
- Market Trends: Biologics are increasingly dominant, with growing financial investment.
FAQs
What is mirikizumab-mrkz used for?
Mirikizumab-mrkz (Omvoh®) is used for the treatment of moderately to severely active ulcerative colitis (UC) in adults and is under review for the treatment of Crohn's disease.
How effective is mirikizumab in long-term treatment?
Mirikizumab has shown that over 80% of UC patients and over 50% of Crohn's disease patients can sustain long-term remission and relief from symptoms over three to five years.
What is the safety profile of mirikizumab?
The safety profile of mirikizumab is consistent with its known adverse event profile, with manageable rates of serious adverse events and treatment discontinuations.
How does mirikizumab impact healthcare budgets?
Introducing mirikizumab to formulary is expected to be relatively budget-neutral or even cost-saving, with minimal incremental costs over three years.
Is mirikizumab approved globally?
Omvoh® is approved in 44 countries and has pending marketing authorization applications in several other countries, including the U.S., Canada, Europe, Japan, and China.
Sources
- PR Newswire: "Lilly's mirikizumab is first and only IL23p19 antagonist to report long-term multi-year sustained efficacy and safety data for both ulcerative colitis and Crohn's disease"[1].
- Oxford Academic: "Budget Impact of Mirikizumab-MRKZ in the Treatment of Moderately to Severely Active Ulcerative Colitis"[2].
- FTC: "Biologics Market Dynamics: Setting the Stage for Biosimilars"[3].
- PR Newswire: "Lilly reports one-year histologic outcomes in Phase 3 study of mirikizumab compared to ustekinumab for Crohn's disease"[4].
- Lilly Investor Relations: "Lilly's mirikizumab is first and only IL23p19 antagonist to report long-term multi-year sustained efficacy data in both ulcerative colitis and Crohn's disease"[5].
Last updated: 2024-12-22
