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