Welcome!

News Feed Item

New Class of Treatment for Overactive Bladder Approved in Europe

CHERTSEY, England, January 11, 2013 /PRNewswire/ --

A new treatment, BETMIGA[TM] (mirabegron) has received approval from the European Commission (EC) for the treatment of overactive bladder (OAB) symptoms in adults.[1] Mirabegron represents the first new class of oral treatment in OAB for over 30 years. Currently around half of patients discontinue OAB treatment after only three months, often due to lack of efficacy or side effects,[2],[3] so it is important that doctors will now be able to offer patients an alternative treatment that works in a different way.

OAB is defined as urinary urgency, with or without urgency incontinence, usually with increased daytime frequency and nocturia (waking up at night one or more times to empty the bladder).[4] OAB affects more than 400 million people worldwide.[5]In Europe,OAB affects approximately 17% of men and women and increases to 30-40% for those aged over 75 years.[6] In a survey carried out in OAB patients, 65% felt OAB had adversely affected their daily life.[6] Symptoms can affect family, social and work life, as well as mental and physical wellbeing,[7] and across OAB patients, depression scores are higher, whilst quality of life scores are lower.[8]

Mirabegron will offer doctors an alternative to antimuscarinic agents, the only other class of approved oral treatment previously available for OAB. Mirabegron has a completely different mechanism of action to antimuscarinics;[9] it improves the storage capacity of the bladder without inhibiting bladder voiding, decreasing the number of times patients need to visit the toilet.[10] Dry mouth is one of the most common and bothersome side effects of antimuscarinics and often the reason for discontinuation of treatment.  In comparison, studies have shown that mirabegron has a low incidence of treatment-associated side effects, including dry mouth.[9],[11],[12],[13],[14]

Dr Ayad Abdulahad, Vice President Medical Affairs and Health Economics for Astellas Pharma Europe Ltd. commented: "This is an important landmark highlighting Astellas' continued service to patients with overactive bladder, and we are delighted to be able to make a new treatment available to them.  We know that many patients discontinue their current treatments as a result of bothersome side effects or because they simply don't feel they are getting a worthwhile benefit.  We really hope that Betmiga[TM] can help change that and allow patients, whose lives are significantly disrupted by OAB on a daily basis, the opportunity to think about something other than their symptoms."  

"The introduction of mirabegron should lead to a shift in how we treat OAB symptoms in adults. It has been over 30 years since a new class of oral treatment was available for OAB patients so we are looking forward to being able to offer an effective medication without the more bothersome side effects associated with antimuscarinics," commented Professor Chris Chapple, Consultant Urological Surgeon at Sheffield Teaching Hospitals and Lead Investigator of the mirabegron 12 month safety and tolerability study. "I see patients every day who are struggling to cope with this chronic condition. OAB can have a significant impact on a patient's quality of life. The introduction of mirabegron offers existing patients and those newly diagnosed with OAB a real alternative to current treatments."

The European Commission granted approval of mirabegron following the recommendation by the Committee for the Medicinal Products for Human Use (CHMP) in October 2012. They reviewed extensive clinical trial evidence from 7 Phase II / III studies in which over 5,000 patients received mirabegron, including 3 Phase III double-blind, randomised controlled trials conducted in the US and Europe-Australia.[11],[12],[13] In the trials, mirabegron demonstrated superior efficacy compared to placebo in the treatment of symptoms of OAB, with patients needing to visit a toilet significantly less frequently and experiencing fewer incontinence episodes.[11],[12],[13] In the trials, mirabegron was also well tolerated and exhibited a good safety profile.[11],[12],[13] In terms of quality of life, research presented at the 2011 American Urological Association (AUA) annual congress demonstrated that patients with OAB who received mirabegron reported significant improvements in treatment satisfaction, symptom bother, disease perception and quality of life, in comparison with patients taking a placebo.[15]

Astellas Pharma Europe Ltd. is an established leader in urology in Europe, committed to improving the lives of patients with urological conditions. Its current urology portfolio includes treatments for benign prostatic hyperplasia (BPH), OAB and prostate cancer. With a strong emphasis on research and development, Astellas is dedicated to finding new treatments to meet unmet medical needs and has a number of treatments for urological conditions in development. As part of its ongoing commitment to the field, Astellas also provides and supports a wide range of educational opportunities for those working in the field of urology, designed to progress professional expertise and improve patient outcomes.

About overactive bladder:

Overactive bladder (OAB) is characterised by symptoms of urinary urgency, with or without urgency incontinence, usually with increased daytime frequency and nocturia (awakening at night one or more times to empty the bladder).[4]

About mirabegron:

Mirabegron is a once daily oral β3-adrenoceptor agonist discovered and developed by Astellas. It is the first compound approved in this new class of treatment for OAB, using a novel mechanism of action compared to antimuscarinics, the current treatment standard.[8] Antimuscarinics work by binding to muscarinic receptors in the bladder and inhibiting involuntary bladder contractions. Mirabegron works by stimulating the β3 receptors in the muscle of the bladder causing relaxation of the bladder muscle, improving the storage capacity of the bladder without impeding bladder voiding.[10]

Astellas submitted a New Drug Application and Market Authorisation Application for mirabegron to the U.S. Food and Drug Administration and the European Medicines Agency in August 2011 and received FDA approval on 28th June 2012, and European approval on 21st December 2012. In Japan, Astellas was granted marketing approval under the trade name of BETANIS® tablet in July 2011. Additionally, there is a recently completed multiregional Phase III study in China, Korea, Taiwan, and India.

About Astellas Pharma Europe Ltd.:

Astellas Pharma Europe Ltd., located in the UK, is the European headquarters of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative pharmaceuticals. The organisation's focus is to deliver outstanding R&D and marketing to continue growing in the world pharmaceutical market. Astellas Pharma Europe Ltd. is responsible for 21 affiliate offices located across Europe, the Middle East and Africa, an R&D site and three manufacturing plants. The company employs approximately 4,300 staff across these regions. For more information about Astellas Pharma Europe, please visit http://www.astellas.eu.

References

  1. Data on file
  2. Benner J.S., Nichol M.B., Rovner E.S., et al. Patient-reported reasons for discontinuing overactive bladder medication. BJU Int 2010; 105(9): 1276-82
  3. Wagg A, Compion G, Fahey A, Siddiqui E. Persistence with prescribed antimuscarinic therapy for overactive bladder: a UK experience. BJUI 2011. Doi:10.1111/j.1464-410X.2012.11023.x
  4. Abrams P. et al. Reviewing the ICS 2002 Terminology Report: The Ongoing Debate. Neurourol Urodyn 2006; 25: 293-294
  5. Irwin D.E., et al.Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction.BJU Int 2011; 108(7):1132-8
  6. Milsom I et al. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int 2001;87(9)760-6
  7. Brown J.S. et al. Comorbidities associated with overactive bladder. Am J Manag Care 2000; 6(11 Suppl): S574-579
  8. Stewart WF et al. Prevalence and burden of overactive bladder in the United States. World J Urol 2003; 20: 327-336
  9. Khullar V et al. Efficacy of mirabegron in patients with and without prior anti-muscarinic therapy for overactive bladder (OAB): Post-hoc analysis of a prospective, randomised European-Australian phase III trial. EAU 2012 Poster AM12-2389
  10. Tyagi P et al.  Mirabegron: safety review Expert Opin. Drug Safety 2011;10.2: 287-294
  11. Khullar V., Amarenco G., Angulo J.C., et al. Efficacy and safety of mirabegron, a β3-adrenoceptor agonist, in patients with overactive bladder: results from a randomized European-Australian phase 3 trial. Eur Urol 2012; http://dx.doi.org/10.1016/j.eururo.2012.10.016
  12. Nitti V., Auerbach A., Martin N., et al. Results of a randomized phase III trial of mirabegron in patients with overactive bladder. J Urol 2012; 10.1016/j.juro.2012.10.017
  13. Van Kerrebroeck P, Barkin J, Castro-Diaz D et al. Randomised, double-blind, placebo-controlled Phase III study to assess the efficacy and safety of mirabegron 25 mg and 50 mg once daily in overactive bladder (OAB). Presented at ICS 2012.
  14. Chapple CR., Kaplan SK., Mitcheson D., et al. Randomized double-blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a β3-adrenoceptor agonist, in overactive bladder. Eur Urol 2012; http://dx.doi.org/ 10.1016/j.eururo.2012.10.048
  15. Nitti V et al. Mirabegron improves patient-reported outcomes in patients with overactive bladder syndrome - results from a North-American study. Presented at AUA 2011

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Sometimes I write a blog just to formulate and organize a point of view, and I think it’s time that I pull together the bounty of excellent information about Machine Learning. This is a topic with which business leaders must become comfortable, especially tomorrow’s business leaders (tip for my next semester University of San Francisco business students!). Machine learning is a key capability that will help organizations drive optimization and monetization opportunities, and there have been some...
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, whic...
The question before companies today is not whether to become intelligent, it’s a question of how and how fast. The key is to adopt and deploy an intelligent application strategy while simultaneously preparing to scale that intelligence. In her session at 21st Cloud Expo, Sangeeta Chakraborty, Chief Customer Officer at Ayasdi, provided a tactical framework to become a truly intelligent enterprise, including how to identify the right applications for AI, how to build a Center of Excellence to oper...
While some developers care passionately about how data centers and clouds are architected, for most, it is only the end result that matters. To the majority of companies, technology exists to solve a business problem, and only delivers value when it is solving that problem. 2017 brings the mainstream adoption of containers for production workloads. In his session at 21st Cloud Expo, Ben McCormack, VP of Operations at Evernote, discussed how data centers of the future will be managed, how the p...
"Storpool does only block-level storage so we do one thing extremely well. The growth in data is what drives the move to software-defined technologies in general and software-defined storage," explained Boyan Ivanov, CEO and co-founder at StorPool, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
ChatOps is an emerging topic that has led to the wide availability of integrations between group chat and various other tools/platforms. Currently, HipChat is an extremely powerful collaboration platform due to the various ChatOps integrations that are available. However, DevOps automation can involve orchestration and complex workflows. In his session at @DevOpsSummit at 20th Cloud Expo, Himanshu Chhetri, CTO at Addteq, will cover practical examples and use cases such as self-provisioning infra...
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory? In her Day 2 Keynote at @DevOpsSummit at 21st Cloud Expo, Aruna Ravichandran, VP, DevOps Solutions Marketing, CA Technologies, was jo...
As Marc Andreessen says software is eating the world. Everything is rapidly moving toward being software-defined – from our phones and cars through our washing machines to the datacenter. However, there are larger challenges when implementing software defined on a larger scale - when building software defined infrastructure. In his session at 16th Cloud Expo, Boyan Ivanov, CEO of StorPool, provided some practical insights on what, how and why when implementing "software-defined" in the datacent...
Blockchain. A day doesn’t seem to go by without seeing articles and discussions about the technology. According to PwC executive Seamus Cushley, approximately $1.4B has been invested in blockchain just last year. In Gartner’s recent hype cycle for emerging technologies, blockchain is approaching the peak. It is considered by Gartner as one of the ‘Key platform-enabling technologies to track.’ While there is a lot of ‘hype vs reality’ discussions going on, there is no arguing that blockchain is b...
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across business networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost as well as advance trade. Are you curious about how Blockchain is built for business? In her session at 21st Cloud Expo, René Bostic, Technical VP of the IBM Cloud Unit in North America, discussed the b...
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
Is advanced scheduling in Kubernetes achievable?Yes, however, how do you properly accommodate every real-life scenario that a Kubernetes user might encounter? How do you leverage advanced scheduling techniques to shape and describe each scenario in easy-to-use rules and configurations? In his session at @DevOpsSummit at 21st Cloud Expo, Oleg Chunikhin, CTO at Kublr, answered these questions and demonstrated techniques for implementing advanced scheduling. For example, using spot instances and co...
The use of containers by developers -- and now increasingly IT operators -- has grown from infatuation to deep and abiding love. But as with any long-term affair, the honeymoon soon leads to needing to live well together ... and maybe even getting some relationship help along the way. And so it goes with container orchestration and automation solutions, which are rapidly emerging as the means to maintain the bliss between rapid container adoption and broad container use among multiple cloud host...
The cloud era has reached the stage where it is no longer a question of whether a company should migrate, but when. Enterprises have embraced the outsourcing of where their various applications are stored and who manages them, saving significant investment along the way. Plus, the cloud has become a defining competitive edge. Companies that fail to successfully adapt risk failure. The media, of course, continues to extol the virtues of the cloud, including how easy it is to get there. Migrating...
Imagine if you will, a retail floor so densely packed with sensors that they can pick up the movements of insects scurrying across a store aisle. Or a component of a piece of factory equipment so well-instrumented that its digital twin provides resolution down to the micrometer.