|By PR Newswire||
|January 11, 2013 03:31 AM EST||
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. 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,, 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). OAB affects more than 400 million people worldwide.In Europe,OAB affects approximately 17% of men and women and increases to 30-40% for those aged over 75 years. In a survey carried out in OAB patients, 65% felt OAB had adversely affected their daily life. Symptoms can affect family, social and work life, as well as mental and physical wellbeing, and across OAB patients, depression scores are higher, whilst quality of life scores are lower.
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; it improves the storage capacity of the bladder without inhibiting bladder voiding, decreasing the number of times patients need to visit the toilet. 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.,,,,
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.,, 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.,, In the trials, mirabegron was also well tolerated and exhibited a good safety profile.,, 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.
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).
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. 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.
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.
- Data on file
- 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
- 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
- Abrams P. et al. Reviewing the ICS 2002 Terminology Report: The Ongoing Debate. Neurourol Urodyn 2006; 25: 293-294
- 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
- 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
- Brown J.S. et al. Comorbidities associated with overactive bladder. Am J Manag Care 2000; 6(11 Suppl): S574-579
- Stewart WF et al. Prevalence and burden of overactive bladder in the United States. World J Urol 2003; 20: 327-336
- 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
- Tyagi P et al. Mirabegron: safety review Expert Opin. Drug Safety 2011;10.2: 287-294
- 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
- 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
- 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.
- 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
- 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
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Oct. 9, 2015 01:45 PM EDT Reads: 122
The IoT is upon us, but today’s databases, built on 30-year-old math, require multiple platforms to create a single solution. Data demands of the IoT require Big Data systems that can handle ingest, transactions and analytics concurrently adapting to varied situations as they occur, with speed at scale. In his session at @ThingsExpo, Chad Jones, chief strategy officer at Deep Information Sciences, will look differently at IoT data so enterprises can fully leverage their IoT potential. He’ll sha...
Oct. 9, 2015 01:45 PM EDT Reads: 555
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi's VP Business Development and Engineering, will explore the IoT cloud-based platform technologies driv...
Oct. 9, 2015 01:45 PM EDT
DevOps has often been described in terms of CAMS: Culture, Automation, Measuring, Sharing. While we’ve seen a lot of focus on the “A” and even on the “M”, there are very few examples of why the “C" is equally important in the DevOps equation. In her session at @DevOps Summit, Lori MacVittie, of F5 Networks, will explore HTTP/1 and HTTP/2 along with Microservices to illustrate why a collaborative culture between Dev, Ops, and the Network is critical to ensuring success.
Oct. 9, 2015 01:30 PM EDT Reads: 166
There are many considerations when moving applications from on-premise to cloud. It is critical to understand the benefits and also challenges of this migration. A successful migration will result in lower Total Cost of Ownership, yet offer the same or higher level of robustness. Migration to cloud shifts computing resources from your data center, which can yield significant advantages provided that the cloud vendor an offer enterprise-grade quality for your application.
Oct. 9, 2015 01:30 PM EDT Reads: 261
There will be 20 billion IoT devices connected to the Internet soon. What if we could control these devices with our voice, mind, or gestures? What if we could teach these devices how to talk to each other? What if these devices could learn how to interact with us (and each other) to make our lives better? What if Jarvis was real? How can I gain these super powers? In his session at 17th Cloud Expo, Chris Matthieu, co-founder and CTO of Octoblu, will show you!
Oct. 9, 2015 01:15 PM EDT
As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership ability. Many are unable to effectively engage and inspire, creating forward momentum in the direction of desired change. Renowned for its approach to leadership and emphasis on their people, organizations increasingly look to our military for insight into these challenges.
Oct. 9, 2015 01:15 PM EDT Reads: 134
Overgrown applications have given way to modular applications, driven by the need to break larger problems into smaller problems. Similarly large monolithic development processes have been forced to be broken into smaller agile development cycles. Looking at trends in software development, microservices architectures meet the same demands. Additional benefits of microservices architectures are compartmentalization and a limited impact of service failure versus a complete software malfunction....
Oct. 9, 2015 01:15 PM EDT Reads: 245
For almost two decades, businesses have discovered great opportunities to engage with customers and even expand revenue through digital systems, including web and mobile applications. Yet, even now, the conversation between the business and the technologists that deliver these systems is strained, in large part due to misaligned objectives. In his session at DevOps Summit, James Urquhart, Senior Vice President of Performance Analytics at SOASTA, Inc., will discuss how measuring user outcomes –...
Oct. 9, 2015 01:00 PM EDT Reads: 455
As a company adopts a DevOps approach to software development, what are key things that both the Dev and Ops side of the business must keep in mind to ensure effective continuous delivery? In his session at DevOps Summit, Mark Hydar, Head of DevOps, Ericsson TV Platforms, will share best practices and provide helpful tips for Ops teams to adopt an open line of communication with the development side of the house to ensure success between the two sides.
Oct. 9, 2015 01:00 PM EDT Reads: 592
SYS-CON Events announced today that ProfitBricks, the provider of painless cloud infrastructure, will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. ProfitBricks is the IaaS provider that offers a painless cloud experience for all IT users, with no learning curve. ProfitBricks boasts flexible cloud servers and networking, an integrated Data Center Designer tool for visual control over the...
Oct. 9, 2015 01:00 PM EDT Reads: 781
Recently announced Azure Data Lake addresses the big data 3V challenges; volume, velocity and variety. It is one more storage feature in addition to blobs and SQL Azure database. Azure Data Lake (should have been Azure Data Ocean IMHO) is really omnipotent. Just look at the key capabilities of Azure Data Lake:
Oct. 9, 2015 01:00 PM EDT Reads: 306
The IoT market is on track to hit $7.1 trillion in 2020. The reality is that only a handful of companies are ready for this massive demand. There are a lot of barriers, paint points, traps, and hidden roadblocks. How can we deal with these issues and challenges? The paradigm has changed. Old-style ad-hoc trial-and-error ways will certainly lead you to the dead end. What is mandatory is an overarching and adaptive approach to effectively handle the rapid changes and exponential growth.
Oct. 9, 2015 01:00 PM EDT Reads: 164
DevOps is here to stay because it works. Most businesses using this methodology are already realizing a wide range of real, measurable benefits as a result of implementing DevOps, including the breakdown of inter-departmental silos, faster delivery of new features and more stable operating environments. To take advantage of the cloud’s improved speed and flexibility, development and operations teams need to work together more closely and productively. In his session at DevOps Summit, Prashanth...
Oct. 9, 2015 12:53 PM EDT
Achim Weiss is Chief Executive Officer and co-founder of ProfitBricks. In 1995, he broke off his studies to co-found the web hosting company "Schlund+Partner." The company "Schlund+Partner" later became the 1&1 web hosting product line. From 1995 to 2008, he was the technical director for several important projects: the largest web hosting platform in the world, the second largest DSL platform, a video on-demand delivery network, the largest eMail backend in Europe, and a universal billing syste...
Oct. 9, 2015 12:45 PM EDT Reads: 167