Neuraceq Receives Expanded Indication for Diagnosis and Monitoring of Individuals with Alzheimer’s

The Food and Drug Administration (FDA) has approved an update to the labeling of Neuraceq (florbetaben F18 injection; Life Molecular Imaging, Boston, MA), expanding the product’s indication to include use in helping to identify appropriate candidates to receive treatment with amyloid-targeting therapies as well as for therapy monitoring in those diagnosed with Alzheimer disease (AD). Neuraceq is a radioactive diagnostic agent initially approved for use in PET imaging of amyloid-β plaques in adults with cognitive impairment who are under evaluation for AD. The agent is designed to selectively bind to amyloid plaques and enable their detection by PET imaging, assisting in determining whether AD pathology is contributing to a patient’s cognitive impairment. The updated indication also recognizes the role of quantitative amyloid plaque metrics alongside visual interpretation, offering clinicians enhanced precision in evaluating amyloid burden.

“This FDA action is a major advancement in Alzheimer's diagnostics," said Andrew Stephens, Chief Medical Officer at Life Molecular Imaging. "Updating the Neuraceq label to reflect the revised Appropriate Use Criteria for amyloid PET enhances clinicians' ability to support patient decision making and identify individuals who may benefit from amyloid-targeting treatment---ultimately contributing to improved patient outcomes.”