25 June 2025 -  Eli Lilly announced that the US FDA has approved a label update for Amyvid (florbetapir F 18 injection) for intravenous use. Amyvid is used for brain imaging to estimate amyloid plaque density in patients with cognitive impairment being evaluated for Alzheimer’s disease and other causes of cognitive decline.

The label update includes the following:

• Revises how Amyvid can be used to estimate plaque density in patients being evaluated for Alzheimer’s disease and other causes of cognitive decline and in patients who are potential candidates for amyloid-targeting therapy.
• Provides a new indication for the selection of patients for amyloid-targeting therapy.
• Quantification of amyloid plaque levels can be used in conjunction with the visual interpretation.
• Updates the clinical studies section of the label to note that amyloid beta positron emission tomography (PET) scans have been used to assess reduction of plaque in some clinical trials of amyloid-targeting therapies as also described in the prescribing information of the therapeutic products.

Read Eli Lilly press release