|By PR Newswire||
|February 11, 2013 09:39 AM EST||
HIGH WYCOMBE, England, February 11, 2013 /PRNewswire/ --
- Today, the SMC announced that Rienso has been accepted for restricted use within NHS Scotland for the treatment of iron deficiency anaemia (IDA) in non-haemodialysis dependent adult patients with chronic kidney disease (CKD) when oral iron preparations are ineffective or cannot be used
- The clinical efficacy and safety of Rienso has been assessed in over 1,500 subjects from its clinical development programme, and supported by observational data in more than 8,600 patients and 33,000 doses administered in clinical practice1-3
- Rienso offers a convenient and cost-competitive alternative for delivering a repletion course of IV iron, and requires fewer bolus injections over a shorter period of time when compared to most other IV iron preparations1,4-8
- Takeda looks forward to making Rienso available to patients in Scotland as part of its ongoing commitment to improving management of IDA
Today, Takeda UK announces the Scottish Medicines Consortium's (SMC) acceptance of Rienso (ferumoxytol), a new intravenous (IV) iron therapy to treat iron deficiency anaemia (IDA) restricted to non-haemodialysis dependent adult patients with chronic kidney disease (CKD) when oral iron preparations are ineffective or cannot be used. All eligible patients in NHS Scotland will now be able to receive Rienso, offering a convenient and cost-effective alternative to current IV iron therapies.1,4-8
"Rienso will be a valuable addition to the currently available therapies for IDA as an effective and convenient method for delivering high dose iron; a significant consideration for non-dialysis patients who maintain an independent lifestyle. Its acceptance by the SMC will be of real benefit to the Scottish renal community." - Professor Alan Jardine, University of Glasgow.
Anaemia continues to place a significant burden on the daily lives of CKD patients, despite the availability of treatments to address the condition.9 Effective and efficient delivery of high doses of IV iron can lead to less disruption to the daily life of CKD patients, brought about by less time spent away from their home, family and work.8 Additionally, fewer patient visits can help improve the efficiency of service delivery leading to cost savings for the NHS.8
Marketing authorisation for Rienso was granted by the European Commission on 15 June 2012.1 Administered as a rapid IV injection, Rienso can be given to most adults as two x 510 mg doses administered 2-8 days apart, the benefits of which are rapid repletion of iron stores in anaemic CKD patients, with fewer bolus injections when compared to most other IV iron preparations.1,4-8 Rienso also offers the NHS a cost-competitive solution when compared to the alternative high bolus dose IV iron.7
Iron deficiency is a common cause of anaemia often seen in the later stages of CKD, and can have a profound impact on patients' lives, causing fatigue, shortness of breath and an increase in the risk of cardiovascular (CV) complications including congestive heart failure.9 Management of IDA is therefore an important aspect of care for patients with CKD and in Scotland alone, over 11,000 non-haemodialysis dependent CKD patients are estimated to suffer from anaemia.10
"Takeda are committed to improving the lives of patients worldwide, particularly in CKD, a profoundly debilitating condition for the patients who suffer from it. Acceptance of Rienso by the SMC marks an important milestone in providing physicians with a valuable alternative in the management of CKD patients with IDA in Scotland." - Yasuhiro Fukutomi, Managing Director of Takeda UK.
Rienso has been shown in clinical studies to significantly increase haemoglobin levels, with a similar overall treatment-related adverse event rate as compared to oral iron across the spectrum of CKD; based on data from over 1,500 subjects.1 Compared to the most widely prescribed IV iron preparation, the FIRST (Ferumoxytol Compared to Iron Sucrose Trial) study demonstrated that Rienso, delivered as two injections of 510 mg within 2-8 days, had a similar safety and comparable efficacy profile to 1 g of iron sucrose dosed as 100 mg or 200 mg over 5 to 10 injections within 2-2.5 weeks.11
Moreover, these data are supported by additional retrospective analyses conducted in the United States involving more than 8,600 patients and more than 33,300 administered doses of Rienso.2,3
NOTES FOR EDITORS
Recommendation from the SMC
ADVICE: following a full submission
Ferumoxytol (Rienso®) is accepted for restricted use within NHS Scotland.
Indication under review: Intravenous treatment of iron deficiency anaemia in adult patients with chronic kidney disease.
SMC restriction: treatment of iron deficiency anaemia in non-haemodialysis dependent adult patients with chronic kidney disease when oral iron preparations are ineffective or cannot be used.
In two Phase III studies the mean increase from baseline in haemoglobin was significantly higher for ferumoxytol than oral iron in non-haemodialysis dependent patients with chronic kidney disease. A mixed treatment comparison demonstrated equivalent efficacy outcomes for ferumoxytol versus a range of intravenous iron preparations.
About Rienso® (ferumoxytol)
Ferumoxytol is an IV iron therapy with an approved indication for the treatment of IDA in adult patients with CKD. When patients are iron deficient ferumoxytol can be administered as an initial 510 mg intravenous injection, followed by a second 510 mg intravenous injection 2-8 days later. For patients with Hb ≤10 g/dL, or 10-12 g/dL and > 50 kg in body weight; the recommended course of ferumoxytol is two injections of 510 mg intravenous iron. Ferumoxytol significantly increases Hb levels in CKD patients with IDA, both on dialysis and in patients not on dialysis compared with oral iron. Clinical trials have also highlighted that ferumoxytol is well tolerated.1
Ferumoxytol was developed by AMAG Pharmaceuticals, Inc (AMAG).1 It received marketing approval as Feraheme from the United States Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the United States shortly thereafter. Ferumoxytol received marketing approval in Canada in December 2011, in the European Union in June 2012 and in Switzerland in August 2012, where it will be marketed by Takeda as Rienso®.
A Summary of Product Characteristics is available on the website http://www.medicines.org.uk.
Takeda UK Ltd. is based in High Wycombe, Buckinghamshire and is the UK subsidiary of Takeda Pharmaceuticals Company, responsible for sales and marketing of the company's medicines in the UK.
Located in Osaka, Japan, Takeda Pharmaceutical Company is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine.
Further information about Takeda in the UK is available at http://www.takeda.co.uk.
- Rienso Summary of Product Characteristics (SmPC). Available online at: http://www.medicines.org.uk. Accessed January 2013.
- Schiller B, Bhat P, Sharma A, et al. Safety of Feraheme® (Ferumoxytol) in hemodialysis patients at 3 dialysis chains over a 1-year period. J Am Soc Nephrol 2011; 22: 477A-478A. Abstr FR-PO1573.
- Sharma A, Bhat P, Schiller B, et al. Efficacy of Feraheme® (Ferumoxytol) administration on target hemoglobin levels and other iron parameters across 3 dialysis chains. J Am Soc Nephrol 2011; 22: 485A. Abstr FR-PO1603.
- Venofer SmPC. Available online at: http://www.medicines.org.uk. Accessed January 2013.
- CosmoFer SmPC. Availabe online at: http://www.medicines.org.uk. Accessed January 2013.
- Monofer SmPC. Available online at: http://www.medicines.org.uk. Accessed January 2013.
- Monthly Index of Medical Specialities (MIMS). January 2013.
- Bhandari S. Beyond efficacy and safety - the need for convenient and cost-effective iron therapy in health care. NDT Plus 2011; 4(Suppl 1): i14-i19.
- O'Mara NB. Anemia in patients with chronic kidney disease. Diabetes Spectrum 2008; 21: 12-19.
- Scottish Intercollegiate Guidelines Network. Diagnosis and management of chronic kidney disease. 2008. Available online at: http://www.sign.ac.uk. Accessed January 2013.
- Macdougall IC, McLaughlin J, Fortin GS, Li Z, Strauss WE. The FIRST head-to-head comparison study (Ferumoxytol compared to Iron Sucrose Trial) of the safety and efficacy of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with chronic kidney disease. Presented November 2011 at ASN Kidney Week 2011.
SYS-CON Events announced today the Enterprise IoT Bootcamp, being held November 1-2, 2016, in conjunction with 19th Cloud Expo | @ThingsExpo at the Santa Clara Convention Center in Santa Clara, CA. Combined with real-world scenarios and use cases, the Enterprise IoT Bootcamp is not just based on presentations but with hands-on demos and detailed walkthroughs. We will introduce you to a variety of real world use cases prototyped using Arduino, Raspberry Pi, BeagleBone, Spark, and Intel Edison. Y...
Jul. 24, 2016 11:00 AM EDT Reads: 1,287
What does it look like when you have access to cloud infrastructure and platform under the same roof? Let’s talk about the different layers of Technology as a Service: who cares, what runs where, and how does it all fit together. In his session at 18th Cloud Expo, Phil Jackson, Lead Technology Evangelist at SoftLayer, an IBM company, spoke about the picture being painted by IBM Cloud and how the tools being crafted can help fill the gaps in your IT infrastructure.
Jul. 24, 2016 11:00 AM EDT Reads: 1,994
CenturyLink has announced that application server solutions from GENBAND are now available as part of CenturyLink’s Networx contracts. The General Services Administration (GSA)’s Networx program includes the largest telecommunications contract vehicles ever awarded by the federal government. CenturyLink recently secured an extension through spring 2020 of its offerings available to federal government agencies via GSA’s Networx Universal and Enterprise contracts. GENBAND’s EXPERiUS™ Application...
Jul. 24, 2016 11:00 AM EDT Reads: 1,782
Much of IT terminology is often misused and misapplied. Modernization and transformation are two such terms. They are often used interchangeably even though they mean different things and have very different connotations. Indeed, it is somewhat safe to assume that in IT any transformative effort is likely to also have a modernizing effect, and thus, we can see these as levels of improvement efforts. However, many businesses are being led to believe if they don’t transform now they risk becoming ...
Jul. 24, 2016 11:00 AM EDT Reads: 1,085
"We provide DevOps solutions. We also partner with some key players in the DevOps space and we use the technology that we partner with to engineer custom solutions for different organizations," stated Himanshu Chhetri, CTO of Addteq, in this SYS-CON.tv interview at DevOps at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 24, 2016 11:00 AM EDT Reads: 1,564
Using new techniques of information modeling, indexing, and processing, new cloud-based systems can support cloud-based workloads previously not possible for high-throughput insurance, banking, and case-based applications. In his session at 18th Cloud Expo, John Newton, CTO, Founder and Chairman of Alfresco, described how to scale cloud-based content management repositories to store, manage, and retrieve billions of documents and related information with fast and linear scalability. He addres...
Jul. 24, 2016 10:45 AM EDT Reads: 863
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is 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 largest enterprises – and delivering real results. Am...
Jul. 24, 2016 10:45 AM EDT Reads: 2,121
Aspose.Total for .NET is the most complete package of all file format APIs for .NET as offered by Aspose. It empowers developers to create, edit, render, print and convert between a wide range of popular document formats within any .NET, C#, ASP.NET and VB.NET applications. Aspose compiles all .NET APIs on a daily basis to ensure that it contains the most up to date versions of each of Aspose .NET APIs. If a new .NET API or a new version of existing APIs is released during the subscription peri...
Jul. 24, 2016 10:00 AM EDT Reads: 550
SYS-CON Events announced today that LeaseWeb USA, a cloud Infrastructure-as-a-Service (IaaS) provider, 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. LeaseWeb is one of the world's largest hosting brands. The company helps customers define, develop and deploy IT infrastructure tailored to their exact business needs, by combining various kinds cloud solutions.
Jul. 24, 2016 09:30 AM EDT Reads: 1,055
As companies gain momentum, the need to maintain high quality products can outstrip their development team’s bandwidth for QA. Building out a large QA team (whether in-house or outsourced) can slow down development and significantly increases costs. This eBook takes QA profiles from 5 companies who successfully scaled up production without building a large QA team and includes: What to consider when choosing CI/CD tools How culture and communication can make or break implementation
Jul. 24, 2016 09:00 AM EDT Reads: 1,501
Adding public cloud resources to an existing application can be a daunting process. The tools that you currently use to manage the software and hardware outside the cloud aren’t always the best tools to efficiently grow into the cloud. All of the major configuration management tools have cloud orchestration plugins that can be leveraged, but there are also cloud-native tools that can dramatically improve the efficiency of managing your application lifecycle. In his session at 18th Cloud Expo, ...
Jul. 24, 2016 09:00 AM EDT Reads: 807
The best-practices for building IoT applications with Go Code that attendees can use to build their own IoT applications. In his session at @ThingsExpo, Indraneel Mitra, Senior Solutions Architect & Technology Evangelist at Cognizant, provided valuable information and resources for both novice and experienced developers on how to get started with IoT and Golang in a day. He also provided information on how to use Intel Arduino Kit, Go Robotics API and AWS IoT stack to build an application tha...
Jul. 24, 2016 08:45 AM EDT Reads: 882
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
Jul. 24, 2016 08:30 AM EDT Reads: 2,053
It’s 2016: buildings are smart, connected and the IoT is fundamentally altering how control and operating systems work and speak to each other. Platforms across the enterprise are networked via inexpensive sensors to collect massive amounts of data for analytics, information management, and insights that can be used to continuously improve operations. In his session at @ThingsExpo, Brian Chemel, Co-Founder and CTO of Digital Lumens, will explore: The benefits sensor-networked systems bring to ...
Jul. 24, 2016 08:30 AM EDT Reads: 1,459
"Tintri was started in 2008 with the express purpose of building a storage appliance that is ideal for virtualized environments. We support a lot of different hypervisor platforms from VMware to OpenStack to Hyper-V," explained Dan Florea, Director of Product Management at Tintri, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 24, 2016 08:15 AM EDT Reads: 1,812