|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
The adoption of the Internet Of Things (IoT) is growing and its growth is synonymous with the growth of cloud. As per predictions from IDC: IoT and the Cloud: Within the next five years, more than 90% of all IoT data will be hosted on service provider platforms as cloud computing reduces the complexity of supporting IoT "Data Blending." This means that any organization that wanted to transform themselves using IoT has to automatically embrace the cloud too, especially the public cloud. This b...
Jan. 31, 2015 11:00 AM EST Reads: 1,138
An entirely new security model is needed for the Internet of Things, or is it? Can we save some old and tested controls for this new and different environment? In his session at @ThingsExpo, New York's at the Javits Center, Davi Ottenheimer, EMC Senior Director of Trust, reviewed hands-on lessons with IoT devices and reveal a new risk balance you might not expect. Davi Ottenheimer, EMC Senior Director of Trust, has more than nineteen years' experience managing global security operations and asse...
Jan. 31, 2015 11:00 AM EST Reads: 4,838
The Internet of Things promises to transform businesses (and lives), but navigating the business and technical path to success can be difficult to understand. In his session at @ThingsExpo, Sean Lorenz, Technical Product Manager for Xively at LogMeIn, demonstrated how to approach creating broadly successful connected customer solutions using real world business transformation studies including New England BioLabs and more.
Jan. 31, 2015 10:45 AM EST Reads: 4,768
We certainly live in interesting technological times. And no more interesting than the current competing IoT standards for connectivity. Various standards bodies, approaches, and ecosystems are vying for mindshare and positioning for a competitive edge. It is clear that when the dust settles, we will have new protocols, evolved protocols, that will change the way we interact with devices and infrastructure. We will also have evolved web protocols, like HTTP/2, that will be changing the very core...
Jan. 31, 2015 10:30 AM EST Reads: 4,145
NuoDB just introduced the Swifts 2.1 Release. In this demo at 15th Cloud Expo, Seth Proctor, CTO of NuoDB, Inc., discussed why scaling databases in the cloud is challenging, why building your application on top of the infrastructure that is designed with this in mind makes a difference, and what you can do with NuoDB that simplifies your programming model, your operations model.
Jan. 31, 2015 10:15 AM EST Reads: 2,640
“We are a managed services company. We have taken the key aspects of the cloud and the purposed data center and merged the two together and launched the Purposed Cloud about 18–24 months ago," explained Chetan Patwardhan, CEO of Stratogent, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 31, 2015 10:00 AM EST Reads: 3,351
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's large...
Jan. 31, 2015 10:00 AM EST Reads: 5,429
The Internet of Things is a misnomer. That implies that everything is on the Internet, and that simply should not be - especially for things that are blurring the line between medical devices that stimulate like a pacemaker and quantified self-sensors like a pedometer or pulse tracker. The mesh of things that we manage must be segmented into zones of trust for sensing data, transmitting data, receiving command and control administrative changes, and peer-to-peer mesh messaging. In his session a...
Jan. 31, 2015 10:00 AM EST Reads: 4,038
Enthusiasm for the Internet of Things has reached an all-time high. In 2013 alone, venture capitalists spent more than $1 billion dollars investing in the IoT space. With "smart" appliances and devices, IoT covers wearable smart devices, cloud services to hardware companies. Nest, a Google company, detects temperatures inside homes and automatically adjusts it by tracking its user's habit. These technologies are quickly developing and with it come challenges such as bridging infrastructure gaps,...
Jan. 31, 2015 10:00 AM EST Reads: 4,728
You use an agile process; your goal is to make your organization more agile. But what about your data infrastructure? The truth is, today's databases are anything but agile - they are effectively static repositories that are cumbersome to work with, difficult to change, and cannot keep pace with application demands. Performance suffers as a result, and it takes far longer than it should to deliver new features and capabilities needed to make your organization competitive. As your application an...
Jan. 31, 2015 09:30 AM EST Reads: 3,791
The Industrial Internet revolution is now underway, enabled by connected machines and billions of devices that communicate and collaborate. The massive amounts of Big Data requiring real-time analysis is flooding legacy IT systems and giving way to cloud environments that can handle the unpredictable workloads. Yet many barriers remain until we can fully realize the opportunities and benefits from the convergence of machines and devices with Big Data and the cloud, including interoperability, ...
Jan. 31, 2015 09:00 AM EST Reads: 4,525
Over the last few years the healthcare ecosystem has revolved around innovations in Electronic Health Record (HER) based systems. This evolution has helped us achieve much desired interoperability. Now the focus is shifting to other equally important aspects - scalability and performance. While applying cloud computing environments to the EHR systems, a special consideration needs to be given to the cloud enablement of Veterans Health Information Systems and Technology Architecture (VistA), i.e....
Jan. 31, 2015 09:00 AM EST Reads: 4,307
Things are being built upon cloud foundations to transform organizations. This CEO Power Panel at 15th Cloud Expo, moderated by Roger Strukhoff, Cloud Expo and @ThingsExpo conference chair, addressed the big issues involving these technologies and, more important, the results they will achieve. Rodney Rogers, chairman and CEO of Virtustream; Brendan O'Brien, co-founder of Aria Systems, Bart Copeland, president and CEO of ActiveState Software; Jim Cowie, chief scientist at Dyn; Dave Wagstaff, VP ...
Jan. 31, 2015 09:00 AM EST Reads: 4,421
"SAP had made a big transition into the cloud as we believe it has significant value for our customers, drives innovation and is easy to consume. When you look at the SAP portfolio, SAP HANA is the underlying platform and it powers all of our platforms and all of our analytics," explained Thorsten Leiduck, VP ISVs & Digital Commerce at SAP, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 31, 2015 09:00 AM EST Reads: 3,923
"Desktop as a Service is emerging as a very big trend. One of the big influencers of this – for Esri – is that we have a large user base that uses virtualization and they are looking at Desktop as a Service right now," explained John Meza, Product Engineer at Esri, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 31, 2015 09:00 AM EST Reads: 3,638
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, discussed how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP HANA...
Jan. 31, 2015 09:00 AM EST Reads: 4,170
More and more file-based and machine generated data is being created every day causing exponential data and content growth, and creating a management nightmare for IT managers. What data centers really need to cope with this growth is a purpose-built tiered archive appliance that enables users to establish a single storage target for all of their applications - an appliance that will intelligently place and move data to and between storage tiers based on user-defined policies. In her session a...
Jan. 31, 2015 09:00 AM EST Reads: 4,310
Since 2008 and for the first time in history, more than half of humans live in urban areas, urging cities to become “smart.” Today, cities can leverage the wide availability of smartphones combined with new technologies such as Beacons or NFC to connect their urban furniture and environment to create citizen-first services that improve transportation, way-finding and information delivery. In her session at @ThingsExpo, Laetitia Gazel-Anthoine, CEO of Connecthings, will focus on successful use c...
Jan. 31, 2015 08:45 AM EST Reads: 3,310
The Internet of Things will greatly expand the opportunities for data collection and new business models driven off of that data. In her session at @ThingsExpo, Esmeralda Swartz, CMO of MetraTech, discussed how for this to be effective you not only need to have infrastructure and operational models capable of utilizing this new phenomenon, but increasingly service providers will need to convince a skeptical public to participate. Get ready to show them the money!
Jan. 31, 2015 08:30 AM EST Reads: 4,936
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Jan. 31, 2015 08:30 AM EST Reads: 5,309