The European Commission has granted marketing authorisation for GE Healthcare's Vizamyl (flutemetamol (18F) solution for injection) for positron emission tomography (PET) imaging of beta amyloid neuritic plaque in suspected Alzheimer's disease (AD).
In Europe, Vizamyl is the only PET imaging tracer for detection of amyloid approved for visual interpretation of colour images.
The product is scheduled to be commercially available in selected European countries from early 2015.
According to the company, Vizamyl is indicated for diagnostic use only and should be used in conjunction with a clinical evaluation.
GE Healthcare Life Sciences president and CEO Kieran Murphy said: "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.
"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."
When used in conjunction with a clinical evaluation, 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.
VU University Medical Center professor of Cognitive Neurology and director of the Alzheimer Center Philip Scheltens said: "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.
"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."
The marketing authorisation of Vizamyl in Europe was based on 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.
The company has developed an electronic reader training program (ETP) to instruct physicians in accurate interpretation of Vizamyl images.
Following approval, the ETP will be offered free of charge as online and in-person training in the EU.
Image: Vizamyl PET cases showing examples of negative flutemetamol (18F) PET scan (left) and positive scan (right). Photo: courtesy of GE Healthcare.