|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
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his general session at @DevOpsSummit at 19th Cloud Expo, Eric Robertson, General Manager at CollabNet, will discuss how customers are able to achieve a level of transparency that e...
Oct. 21, 2016 09:30 PM EDT Reads: 613
Effectively SMBs and government programs must address compounded regulatory compliance requirements. The most recent are Controlled Unclassified Information and the EU’s GDPR have Board Level implications. Managing sensitive data protection will likely result in acquisition criteria, demonstration requests and new requirements. Developers, as part of the pre-planning process and the associated supply chain, could benefit from updating their code libraries and design by incorporating changes.
Oct. 21, 2016 09:30 PM EDT Reads: 1,578
SYS-CON Events announced today that Enzu will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Enzu’s mission is to be the leading provider of enterprise cloud solutions worldwide. Enzu enables online businesses to use its IT infrastructure to their competitive advantage. By offering a suite of proven hosting and management services, Enzu wants companies to focus on the core of their online busine...
Oct. 21, 2016 09:15 PM EDT Reads: 1,189
SYS-CON Events announced today that Roundee / LinearHub will exhibit at the WebRTC Summit at @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. LinearHub provides Roundee Service, a smart platform for enterprise video conferencing with enhanced features such as automatic recording and transcription service. Slack users can integrate Roundee to their team via Slack’s App Directory, and '/roundee' command lets your video conference ...
Oct. 21, 2016 09:15 PM EDT Reads: 1,975
SYS-CON Events announced today that SoftNet Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. SoftNet Solutions specializes in Enterprise Solutions for Hadoop and Big Data. It offers customers the most open, robust, and value-conscious portfolio of solutions, services, and tools for the shortest route to success with Big Data. The unique differentiator is the ability to architect and...
Oct. 21, 2016 08:15 PM EDT Reads: 318
In past @ThingsExpo presentations, Joseph di Paolantonio has explored how various Internet of Things (IoT) and data management and analytics (DMA) solution spaces will come together as sensor analytics ecosystems. This year, in his session at @ThingsExpo, Joseph di Paolantonio from DataArchon, will be adding the numerous Transportation areas, from autonomous vehicles to “Uber for containers.” While IoT data in any one area of Transportation will have a huge impact in that area, combining senso...
Oct. 21, 2016 07:15 PM EDT Reads: 241
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Oct. 21, 2016 07:15 PM EDT Reads: 1,608
@ThingsExpo has been named the Top 5 Most Influential Internet of Things Brand by Onalytica in the ‘The Internet of Things Landscape 2015: Top 100 Individuals and Brands.' Onalytica analyzed Twitter conversations around the #IoT debate to uncover the most influential brands and individuals driving the conversation. Onalytica captured data from 56,224 users. The PageRank based methodology they use to extract influencers on a particular topic (tweets mentioning #InternetofThings or #IoT in this ...
Oct. 21, 2016 07:00 PM EDT Reads: 8,103
"Matrix is an ambitious open standard and implementation that's set up to break down the fragmentation problems that exist in IP messaging and VoIP communication," explained John Woolf, Technical Evangelist at Matrix, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Oct. 21, 2016 07:00 PM EDT Reads: 8,923
What are the new priorities for the connected business? First: businesses need to think differently about the types of connections they will need to make – these span well beyond the traditional app to app into more modern forms of integration including SaaS integrations, mobile integrations, APIs, device integration and Big Data integration. It’s important these are unified together vs. doing them all piecemeal. Second, these types of connections need to be simple to design, adapt and configure...
Oct. 21, 2016 06:45 PM EDT Reads: 1,857
The IoT has the potential to create a renaissance of manufacturing in the US and elsewhere. In his session at 18th Cloud Expo, Florent Solt, CTO and chief architect of Netvibes, discussed how the expected exponential increase in the amount of data that will be processed, transported, stored, and accessed means there will be a huge demand for smart technologies to deliver it. Florent Solt is the CTO and chief architect of Netvibes. Prior to joining Netvibes in 2007, he co-founded Rift Technologi...
Oct. 21, 2016 06:45 PM EDT Reads: 2,812
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
Oct. 21, 2016 06:15 PM EDT Reads: 3,011
Kubernetes, Docker and containers are changing the world, and how companies are deploying their software and running their infrastructure. With the shift in how applications are built and deployed, new challenges must be solved. In his session at @DevOpsSummit at19th Cloud Expo, Sebastian Scheele, co-founder of Loodse, will discuss the implications of containerized applications/infrastructures and their impact on the enterprise. In a real world example based on Kubernetes, he will show how to ...
Oct. 21, 2016 05:15 PM EDT Reads: 2,814
@DevOpsSummit has been named the ‘Top DevOps Influencer' by iTrend. iTrend processes millions of conversations, tweets, interactions, news articles, press releases, blog posts - and extract meaning form them and analyzes mobile and desktop software platforms used to communicate, various metadata (such as geo location), and automation tools. In overall placement, @DevOpsSummit ranked as the number one ‘DevOps Influencer' followed by @CloudExpo at third, and @MicroservicesE at 24th.
Oct. 21, 2016 04:30 PM EDT Reads: 3,797
24Notion is full-service global creative digital marketing, technology and lifestyle agency that combines strategic ideas with customized tactical execution. With a broad understand of the art of traditional marketing, new media, communications and social influence, 24Notion uniquely understands how to connect your brand strategy with the right consumer. 24Notion ranked #12 on Corporate Social Responsibility - Book of List.
Oct. 21, 2016 04:15 PM EDT Reads: 1,486