Welcome!

News Feed Item

GE Healthcare Announces European Union Approval of VIZAMYL™ (Flutemetamol (18F) Solution for Injection) for PET Imaging of Beta Amyloid Plaque in Suspected Alzheimer’s Disease

GE Healthcare announced today that VIZAMYL™ (flutemetamol (18F) solution for injection) has received marketing authorisation from the European Commission as a radiopharmaceutical medicinal product indicated for Positron Emission Tomography (PET) imaging of beta amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. VIZAMYL™ is the only PET imaging tracer for detection of amyloid approved in Europe for visual interpretation of colour images and will be commercially available in selected European countries from early 2015. VIZAMYL™ is for diagnostic use only and should be used in conjunction with a clinical evaluation.

VIZAMYL™ PET cases showing examples of negative flutemetamol (18F) PET scan (left) and positive scan ...

VIZAMYL™ PET cases showing examples of negative flutemetamol (18F) PET scan (left) and positive scan (right). Images from VIZAMYL, European Summary of Product Characteristics. Reference: http://www.ema.europa.eu/ema Date: August 2014

“Dementia is one of the biggest health and social challenges in the world and receiving marketing authorisation for VIZAMYL in the European Union (EU) demonstrates our continued commitment to helping to meet this challenge and support the diagnosis of Alzheimer’s disease” said Kieran Murphy, President and CEO, Life Sciences, GE Healthcare. “This approval will provide physicians in the EU with an important tool that may help them better assess specific patients who are being evaluated for Alzheimer’s disease and will also support further research into greatly needed disease modifying agents.”

Alzheimer's disease, the leading cause of dementia, can be challenging to diagnose, as many of the symptoms are similar to other causes of cognitive impairment1. When used in conjunction with a clinical evaluation, using VIZAMYL to detect the accumulation of beta amyloid in the brain may help to confirm an Alzheimer’s disease diagnosis and could potentially have an impact on earlier patient management, including the treatment of symptoms.

“VIZAMYL can help with diagnosis in certain individuals, providing patients and caregivers, along with their healthcare professionals, the opportunity to determine appropriate treatment options and plan for the future,” said Professor Philip Scheltens, Professor of Cognitive Neurology and Director of the Alzheimer Center at the VU University Medical Center, Amsterdam. “Because Alzheimer’s disease and dementia continue to be a major burden on healthcare and society, it is equally important that VIZAMYL will help support and guide further clinical research that is vital in order to develop disease modifying agents.”

Even though disease modifying agents are not yet available, new research released from the GE Healthcare-sponsored Value of Knowing Survey 20142 revealed an overwhelming demand to know about a neurological diagnosis in oneself or their loved ones, even in absence of a cure. The survey found that 74% of respondents would want to know their neurological disease diagnosis, even if there is no cure, and 81% would want to know the diagnosis if someone close to them had an incurable neurological disorder. The ‘Value of Knowing’ is a global survey of 10,000 adults across 10 countries exploring perspectives on incurable neurological disorders including Alzheimer’s (AD) and Parkinson’s (PD). The research was conducted by Millward Brown during June 2014 across 10 countries – Australia, Brazil, China, India, Indonesia, Japan, Russia, South Korea, UK and USA – with 1,000 nationally –representative adult respondents in each market.

The marketing authorisation for VIZAMYL was based on review of data from a series of Phase III clinical trials, including brain autopsy studies which showed high sensitivity and specificity for visual interpretation of flutemetamol (18F) PET images, using beta amyloid pathology as the standard of truth.3,4 Additionally, to instruct physicians in accurate interpretation of VIZAMYL images, GE Healthcare has developed an electronic reader training program (ETP), which, following approval, will be offered free of charge as online and in-person training in the European Union. Images should be interpreted only by readers who have completed the GE Healthcare electronic reader training program.

GE’S COMMITMENT TO IMAGING RESEARCH

VIZAMYL, flutemetamol (18F) is one component of a broad portfolio of investigational diagnostic solutions that GE Healthcare is currently developing in the neurology field. GE Healthcare is taking a comprehensive approach to understanding dementia and AD through its ongoing research to uncover the causes, risks, and physical effects of these diseases. GE Healthcare offers a broad portfolio of imaging resources including cyclotrons and chemistry systems to manufacture PET imaging agents, PET and MR scanners to scan patients, and is developing image analysis software to provide quantification, optimized visualization and reporting tools.

Additionally, GE Healthcare is collaborating with other companies in the pharmaceutical industry to assist in their development of the next generation of therapies. To that end, work is ongoing with potential partners in the industry to understand their strategic needs, and helping to provide imaging support for clinical trials of therapeutic agents.

ABOUT GE HEALTHCARE

GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.

For our latest news, please visit http://newsroom.gehealthcare.com

1Alzheimer’s Association. What is Dementia Patient Information. Available at http://www.alz.org/what-is-dementia.asp. Last accessed August 2014.

2 Value of Knowing 2014. GE Healthcare. Data on file.

3 Ikonomovic M, Buckley C, Smith A et al. [18F]Flutemetamol injection PET images reflect brain amyloid levels. Data presented at Alzheimer's Association® International Conference 2012 (AAIC 2012), Vancouver, BC, Canada.

4 Wolk D, Gamez J, Sadowsky C et. al. Brain autopsy and in vivo cortical brain biopsy trials show a strong concordance between [18F]Flutemetamol PET and amyloid-β pathology. Poster presented at: 64th Annual Meeting of the American Academy of Neurology, April 21-28, 2012; New Orleans, LA.

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in compute, storage and networking technologies, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/...
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Judith Hurwitz is president and CEO of Hurwitz & Associates, a Needham, Mass., research and consulting firm focused on emerging technology, including big data, cognitive computing and governance. She is co-author of the book Cognitive Computing and Big Data Analytics, published in 2015. Her Cloud Expo session, "What Is the Business Imperative for Cognitive Computing?" is scheduled for Wednesday, June 8, at 8:40 a.m. In it, she puts cognitive computing into perspective with its value to the busin...
NHK, Japan Broadcasting, will feature the upcoming @ThingsExpo Silicon Valley in a special 'Internet of Things' and smart technology documentary that will be filmed on the expo floor between November 3 to 5, 2015, in Santa Clara. NHK is the sole public TV network in Japan equivalent to the BBC in the UK and the largest in Asia with many award-winning science and technology programs. Japanese TV is producing a documentary about IoT and Smart technology and will be covering @ThingsExpo Silicon Val...
SYS-CON Events announced today that CollabNet, a global leader in enterprise software development, release automation and DevOps solutions, will be a Bronze Sponsor of SYS-CON's 20th International Cloud Expo®, taking place from June 6-8, 2017, at the Javits Center in New York City, NY. CollabNet offers a broad range of solutions with the mission of helping modern organizations deliver quality software at speed. The company’s latest innovation, the DevOps Lifecycle Manager (DLM), supports Value S...
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
Building a cross-cloud operational model can be a daunting task. Per-cloud silos are not the answer, but neither is a fully generic abstraction plane that strips out capabilities unique to a particular provider. In his session at 20th Cloud Expo, Chris Wolf, VP & Chief Technology Officer, Global Field & Industry at VMware, will discuss how successful organizations approach cloud operations and management, with insights into where operations should be centralized and when it’s best to decentraliz...
The age of Digital Disruption is evolving into the next era – Digital Cohesion, an age in which applications securely self-assemble and deliver predictive services that continuously adapt to user behavior. Information from devices, sensors and applications around us will drive services seamlessly across mobile and fixed devices/infrastructure. This evolution is happening now in software defined services and secure networking. Four key drivers – Performance, Economics, Interoperability and Trust ...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
With billions of sensors deployed worldwide, the amount of machine-generated data will soon exceed what our networks can handle. But consumers and businesses will expect seamless experiences and real-time responsiveness. What does this mean for IoT devices and the infrastructure that supports them? More of the data will need to be handled at - or closer to - the devices themselves.
@DevOpsSummit at Cloud taking place June 6-8, 2017, at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developm...
Cloud Expo, Inc. has announced today that Aruna Ravichandran, vice president of DevOps Product and Solutions Marketing at CA Technologies, has been named co-conference chair of DevOps at Cloud Expo 2017. The @DevOpsSummit at Cloud Expo New York will take place on June 6-8, 2017, at the Javits Center in New York City, New York, and @DevOpsSummit at Cloud Expo Silicon Valley will take place Oct. 31-Nov. 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Translating agile methodology into real-world best practices within the modern software factory has driven widespread DevOps adoption, yet much work remains to expand workflows and tooling across the enterprise. As models evolve from pockets of experimentation into wholescale organizational reinvention, practitioners find themselves challenged to incorporate the culture and architecture necessary to support DevOps at scale. In his session at @DevOpsSummit at 20th Cloud Expo, Anand Akela, Senior...
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).