Last updated: January 1, 2025
Introduction
MYRBETRIQ, known generically as mirabegron, is a beta-3 adrenergic receptor agonist primarily used for the treatment of overactive bladder (OAB) symptoms, including urgency, urgency incontinence, and urinary frequency. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.
Clinical Trials Update
Efficacy and Safety in OAB
MYRBETRIQ has been extensively evaluated in several clinical trials to assess its efficacy and safety in patients with OAB. Three Phase III studies (Studies 178-CL-046, -047, and -074) involved over 3,000 patients and demonstrated statistically significant and clinically relevant improvements in OAB symptoms compared to placebo. These studies showed that MYRBETRIQ, at doses of 25 mg and 50 mg once daily, effectively reduced the frequency of micturitions, urgency, and incontinence episodes[3][4].
Long-Term Safety
A 1-year, randomized, active-controlled safety study further reinforced the safety profile of MYRBETRIQ. This study found no significant differences in safety or effectiveness between patients under 65 years and those 65 years or older. The most common adverse reactions reported were hypertension, nasopharyngitis, urinary tract infections, and headache, which were generally mild and did not differ significantly from the placebo group[4].
Cardiovascular Trials
Recently, the Beta3-LVH trial investigated the use of mirabegron in patients with left ventricular hypertrophy (LVH) to assess its potential in preventing the progression of structural heart disease. Although the trial showed that mirabegron was safe in patients with cardiovascular risk factors, it failed to prevent the progression of structural heart disease. This outcome was attributed to the low expression of beta-3 receptors in the hearts of the study population and the use of a standard therapeutic dose[1].
Market Analysis
Current Market Landscape
The global overactive bladder drug market, valued at $2.2 billion in 2020, is projected to grow at a compound annual growth rate (CAGR) of more than 2% from 2021 to 2030. MYRBETRIQ currently dominates the market, accounting for over 50% of global sales in 2020. The US market is the largest, contributing more than 45% of global sales due to the high prevalence of OAB and the high cost of drug therapy in this region[2][5].
Market Challenges
Despite its dominance, the OAB market faces several challenges. Patent expirations for key products, including MYRBETRIQ, VESIcare, and Toviaz, are expected to lead to generic sales erosion in the early-to-mid forecast period. Additionally, social stigma and lack of awareness about OAB among patients and healthcare professionals result in low diagnosis and treatment rates. Poor persistence and adherence to drug therapy further hinder market growth[2][5].
Future Projections
Market Growth
The market is expected to experience a decline in the early-to-mid forecast period due to patent expiries but will see a boost from the launch of pipeline products in the mid-to-late forecast period. By 2030, the global OAB market is projected to reach $2.8 billion, driven by an aging population and the increasing prevalence of OAB[2][5].
Pipeline Products
The scarcity of late-stage pipeline products is a significant barrier to immediate market growth. However, the potential launch of new therapies, including gene therapies, could revitalize the market. For instance, Urovant Sciences is working on the first gene therapy for OAB, which could offer new treatment options and stimulate market growth[2].
Key Takeaways
- Clinical Efficacy: MYRBETRIQ has demonstrated significant efficacy in reducing OAB symptoms in multiple clinical trials.
- Safety Profile: The drug has a favorable safety profile, with minimal adverse events, and is safe for use in patients with cardiovascular risk factors.
- Market Dominance: MYRBETRIQ is the leading OAB therapy, accounting for over 50% of global sales.
- Market Challenges: Patent expirations, social stigma, and poor adherence to therapy are major challenges facing the OAB market.
- Future Growth: The market is expected to grow, driven by an aging population and the launch of new pipeline products.
FAQs
What is MYRBETRIQ used for?
MYRBETRIQ is used for the treatment of overactive bladder (OAB) symptoms, including urgency, urgency incontinence, and urinary frequency.
What are the common adverse reactions associated with MYRBETRIQ?
Common adverse reactions include hypertension, nasopharyngitis, urinary tract infections, and headache.
How does MYRBETRIQ compare to other OAB treatments?
MYRBETRIQ is a beta-3 adrenergic receptor agonist, which distinguishes it from antimuscarinic drugs. It has shown comparable efficacy to other treatments like tolterodine ER in clinical trials.
What are the market projections for the OAB drug market?
The global OAB market is projected to grow at a CAGR of more than 2% from 2021 to 2030, reaching $2.8 billion by 2030.
Why is the OAB market growth hindered despite high prevalence?
The market growth is hindered by factors such as patent expirations, social stigma, lack of awareness, and poor adherence to therapy.
Sources
- European Society of Cardiology. Mirabegron is safe but fails to prevent remodelling in patients with mild heart disease. Press Release, November 7, 2022.
- ResearchAndMarkets.com. Global Overactive Bladder Drug Forecast and Market Analysis to 2030. Business Wire, January 31, 2022.
- Health Canada. Summary Basis of Decision for Myrbetriq.
- Myrbetriqhcp.com. PILLAR Safety | MYRBETRIQ® (mirabegron ER tablets).
- GlobalData. Overactive Bladder: Global Drug Forecast and Market Analysis to 2030. December 14, 2021.
