Vizamyl wins European approval
The amyloid PET radiotracer F-18 flutemetamol (Vizamyl) has been given the CE mark from the European Commission authorizing marketing of the drug across Europe, GE Healthcare announced yesterday.
Vizamyl now can be marketed as a radiopharmaceutical for amyloid PET imaging of neuritic plaque density in the evaluation of Alzheimer’s disease and other conditions associated with cognitive decline.
“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, MD, PhD, professor of cognitive neurology and director of the Alzheimer Center at the VU University Medical Center, Amsterdam, in GE’s official statement. “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.”
Now three amyloid radiotracers are approved for clinical use in Europe: Vizamyl, Amyvid (F-18 Florbetapir) and Neuraceq (F-18 florbetaben). GE officials say that Vizamyl is the only PET radiotracer approved for diagnostic amyloid imaging in Europe that can be used in visual interpretation of color scans.
GE anticipates commercial availability of Vizamyl in parts of Europe beginning the first quarter 2015. The FDA approved Vizamyl for U.S. clinical use last October.