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# Lilly’s Amyvid Gets Updated Label
- URL: https://www.fdaweb.com/lillys-amyvid-gets-updated-label/
- Published: 2025-06-25T12:00:00.000Z
- Updated: 2026-09-14T15:15:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159418

FDA has approved an updated label for Eli Lilly’s Amyvid (florbetapir F 18 injection) 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:

- Revising 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.
- Providing a new indication for the selection of patients for amyloid-targeting therapy.
- Quantification of amyloid plaque levels, which can be used in conjunction with visual interpretation.
- Updating 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

Amyvid is a radioactive diagnostic agent tagged with the radioisotope fluorine-18\. “Once Amyvid is injected into a vein, it travels through the bloodstream and into the brain, binding to amyloid plaques,” Lilly says. “Amyvid produces a positron signal, which is detected by a PET scanner and used to create a brain image.”