News | September 02, 2014

GE Healthcare Gains European Approval of Vizamyl PET Imaging Agent for Alzheimer’s Disease

PET imaging agent receives marketing authorization from European Commission

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

September 2, 2014 — GE Healthcare announced that the Vizamyl flutemetamol (18F) solution for injection has received marketing authorization 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 the detection of amyloid approved in Europe for visual interpretation of color 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.

“Dementia is one of the biggest health and social challenges in the world and receiving marketing authorization for Vizamyl in the European Union 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 AD 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 impairment. 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 AD 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 Philip Scheltens, M.D., Ph.D., professor of cognitive neurology and director of the Alzheimer Center at the VU University Medical Center, Amsterdam. “Because AD 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.”

The marketing authorization 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. 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 EU. Images should be interpreted only by readers who have completed the GE Healthcare electronic reader training program.

For more information: www.gehealthcare.com

Related Content

PET/CT Changes Care for 59 Percent of Suspected Recurrent Prostate Cancer Cases
News | Prostate Cancer | June 13, 2018
A recently presented investigational clinical trial evaluated the impact of 18F fluciclovine positron emission...
American Society of Neuroradiology Honors Peter Chang with Cornelius G. Dyke Memorial Award
News | Neuro Imaging | June 13, 2018
Peter Chang, M.D., current neuroradiology fellow at UCSF and recently recruited co-director of the UCI Center for...
Reduced hippocampal volume on MRI

This figure shows reduced hippocampal volume over the course of 6 years as seen on progressive volumetric analysis and also coronal MRI evaluations (arrows).Progressive volume loss in the mesial temporal lobe on MRI is a characteristic imaging feature of AD. This patient was a case of Alzheimer’s Dementia.

 

News | Neuro Imaging | June 12, 2018
According to a UCLA Medical Center study, a new technology shows the potential to help doctors better determine when...
Nuclear imaging scan showing very good tissue delineation. Scan performed on a Biograph Vision positron emission tomography/computed tomography (PET-CT) system from Siemens Healthineers.

Nuclear imaging scan showing very good tissue delineation. It offers crisp overall image quality and sharply delineates the muscle and fat planes, vertebral margins and end plates, billiary radicals, renal calyces, aortic wall and papillary muscles of the heart. Scan performed on a Biograph Vision positron emission tomography/computed tomography (PET-CT) system from Siemens Healthineers.

Technology | PET-CT | June 05, 2018
June 5, 2018 — The U.S.
Emerging Trends in Nuclear Medicine
Feature | Nuclear Imaging | June 04, 2018 | By Jeff Zagoudis
Nuclear imaging and its various modalities have long played an important role in the diagnosis and treatment of numer
PET Imaging Agent Could Provide Early Diagnosis of Rheumatoid Arthritis

Coronal 18F-FEDAC PET/CT section of a mouse with collagen-induced arthritis. (A) On day 23 and day 37, increased uptake is noted in the front and hind paws of this mouse with collagen-induced arthritis. (B) Predictive performance of day 23 18F-FEDAC uptake for the development of clinical arthritis. ROC = receiver operating characteristic; Sn = sensitivity; Sp = specificity. Credit: Seoul National University and Ewha Womans University, Seoul, South Korea

News | PET Imaging | May 17, 2018
A novel positron emission tomography (PET) tracer developed by Korean researchers can visualize joint inflammation and...
PET Imaging Shows Protein Clumping May Contribute to Heart Failure Development
News | PET Imaging | May 11, 2018
A team led by Johns Hopkins University Researchers has discovered that protein clumps appear to accumulate in the...
Impaired Brain Pathways May Cause Attention Problems After Stroke
News | Neuro Imaging | May 10, 2018
Damage to some of the pathways that carry information throughout the brain may be responsible for attention deficit in...
News | Radiopharmaceuticals and Tracers | May 09, 2018
Blue Earth Diagnostics signed an exclusive, worldwide agreement with Scintomics GmbH, Germany, a specialist in...
Functional MRI Assesses Crocodile Brain Listening to Classical Music

A research team from Ruhr-Universität Bochum (RUB) used functional MRI to assess the brain patterns of a Nile crocodile and determine what happens when the animal hears complex sounds. Image courtesy of Felix Ströckens, M.D./Proceedings of the Royal Society B: Biological Sciences

News | Magnetic Resonance Imaging (MRI) | May 08, 2018
May 8, 2018 — In a first, an international research team from the Department of Biopsychology at Ruhr-Universität Boc
Overlay Init