Eli Lilly and Company and Avid Radiopharmaceuticals have gained positive CHMP opinion for Amyvid (Florbetapir F 18 injection) for the use as a diagnostic tool for positron emission tomography (PET) imaging of beta-amyloid plaque density in patients with cognitive impairment.
The European Commission is yet to approve the product that should be used in combination with a clinical evaluation.
Amyvid global brand leader Diane Bakaysa said, "If approved in the European Union, Amyvid may offer an innovative and appropriate adjunct to other diagnostic evaluations for adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive impairment."
The radioactive diagnostic agent was indicated for PET imaging of beta-amyloid neuritic plaque density in cognitive impairment patients being evaluated for Alzheimer's Disease and other causes of cognitive decline in the US.
A positive Amyvid scan signifies moderate to frequent amyloid plaques while a negative Amyvid scan specifies sparse to no amyloid plaques.
