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GE Healthcare gets EU approval of VIZAMYL

VIZAMYL has received marketing authorisation from the European Commission for PET imaging of beta amyloid plaque in suspected Alzheimer’s disease.

It will be commercially available in selected European countries from early 2015. 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.

“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.”

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.