By Fineline Cube 
US-based Eli Lilly & Co. (NYSE: LLY) announced the US Food and Drug Administration (FDA) has approved a label update for Amyvid (florbetapir F18 injection). The revised label broadens the use of this radioactive diagnostic agent for brain imaging in assessing amyloid plaque density in Alzheimer’s disease (AD) and other cognitive impairments.
Label Updates
The updated label provides revised guidance on using Amyvid to evaluate plaque density in AD patients and those with cognitive decline who may be candidates for amyloid-targeting therapies. It introduces new indications for patient selection in amyloid-targeted therapy and clarifies that quantification of amyloid plaque levels may be used alongside visual interpretation.
Clinical Studies Section
The label now includes an updated clinical studies section noting that amyloid beta PET imaging has been used to assess plaque reduction in clinical trials of anti-amyloid therapies, as described in respective prescribing information.
Amyvid Mechanism
Amyvid, labeled with fluorine-18, binds to amyloid plaques in the brain. When injected intravenously, it generates images via PET scanning. Qualified radiologists interpret these images to detect moderate to frequent neuritic plaque presence, aiding clinicians in diagnostic and treatment decisions.-Fineline Info & Tech