FDA Approves Updated Amyloid PET Labels for Alzheimer’s Diagnosis

The U.S. FDA has approved updated labels for two key PET imaging agents used in diagnosing and managing Alzheimer's disease: Eli Lilly's Amyvid and GE HealthCare's Vizamyl. Both label updates now allow not only visual estimation but also quantification of amyloid plaque density in the brain, which aids in more accurate diagnosis, patient selection for amyloid-targeting therapies, and monitoring of treatment response. Amyvid's update supports its use in identifying candidates for amyloid-targeting therapies and highlights its role in clinical trials assessing plaque reduction. Similarly, Vizamyl's expanded indications include diagnosing Alzheimer's, predicting progression to dementia, and monitoring therapy effectiveness, with the removal of previous restrictions against its use for treatment monitoring. These advancements align with revised Alzheimer’s Association criteria recognizing amyloid PET scans as sufficient for diagnosis and reflect growing emphasis on precision care in Alzheimer's management. Experts emphasize that quantification enhances diagnostic confidence and facilitates timely, appropriate treatment decisions for patients with cognitive impairment.