FDA Approves Amyvid Injection Updated Label to Support Diagnosis of Alzheimer Disease

The FDA approved a label update for Amyvid, a florbetapir F 18 injection (Eli Lilly & Co.), for intravenous use. The injection is utilized for brain imaging to estimate the density of amyloid plaque in patients with cognitive impairment who are being evaluated for Alzheimer disease and other causes of cognitive decline.¹

Image credit: Nomad_Soul | stock.adobe.com

Amyvid is a radioactive diagnostic agent that is tagged with fluorine-18, a radioisotope. It is injected into the vein and travels through the bloodstream and into the brain to bind to amyloid plaques. It produces a positron signal that is detected by a PET scanner and utilized to create a brain image. An Amyvid-trained radiologist interprets the image, evaluates it for the presence or absence of significant amyloid plaques in the brain, and then reports the findings to the referring health care professional who determines the next steps.^1,2

Of note, amyloid PET—which includes Amyvid—is broadly covered by Medicare and other insurance plans. Because coverage varies across insurance plans, it is crucial that patients and health care providers check each individual plan for coverage details.¹

The label update consists of multiple changes. It revises how Amyvid can be used to estimate plaque density in patients who are being evaluated for Alzheimer disease and other causes of cognitive decline, as well as in potential candidates for amyloid-targeting therapy; provides a new indication for the selection of patients for amyloid-targeting therapy; alters the quantification of amyloid plaque levels that can be used in conjunction with the visual interpretation; and updates the clinical studies section of the label to note that amyloid beta 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.^1,2

Amyvid’s effectiveness was initially evaluated in 2 single-arm clinical studies that enrolled participants with a range of cognitive function. These individuals underwent an Amyvid injection and scan, and these images were then interpreted using a clinically applicable binary image interpretation method. Study 1 specifically evaluated the performance characteristics of Amyvid, whereas study 2 evaluated the inter-reader and intra-reader reproducibility of image interpretation.³

At autopsy in study 1, the global brain neuritic plaque density categories were frequent (n = 30), moderate (n = 9), sparse (n = 5), and none (n = 15). Additionally, study 2 found that the median of correct, false negative, and false positive reads were 55 (range: 45–56), 3 (range: 2–12), and 1 (range: 0–2), respectively, for in-person training, and were 51 (range: 46–54), 7 (range: 3–12), and 1 (range: 1–2), respectively, for electronic media training. Further, the intra-reader reproducibility analyses demonstrated that between the 2 readings for each of the 33 duplicate scans, 1 of the 5 readers had complete agreement for all 33 scans, 2 had discrepant reads for a single scan, 1 had discrepant reads for 2 scans, and another reader had discrepant reads for 3 scans.³

Some adverse events were reported during clinical trials by patients who received Amyvid, such as headache, muscle or joint pain, high blood pressure, nausea, tiredness, and injection site reactions (eg, bleeding, irritation, pain at injection site). These were not considered severe and occurred in a small population (about 0.4%) of participants.^3,4

“Nearly 80% of Americans would prefer to know if they have an Alzheimer’s diagnosis before their memory and thinking symptoms disrupt daily life³, highlighting the importance of advanced diagnostic tools like amyloid PET and blood biomarker testing,” Mark Mintun, MD, group vice president of neuroscience research & development, Lilly, said in a news release. “The modernization of Amyvid’s label is a significant step in advancing Alzheimer’s care, enabling physicians to help patients make informed decisions, being evaluated for or to aid in the selection of patients who are indicated for amyloid-targeting therapy.”¹

REFERENCES

1. Eli Lilly. FDA approves updated label for Lilly’s Amyvid (florbetapir F 18 injection) to support diagnosis of Alzheimer’s disease in patients. News release. June 25, 2025. Accessed June 26, 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-updated-label-lillys-amyvid-florbetapir-f-18

2. Eli Lilly. Amyvid® (florbetapir F18 injection). Accessed June 26, 2025. https://medical.lilly.com/us/products/answers/how-does-amyvid-florbetapir-f-18-work-159043

3. Eli Lilly. Highlights of prescribing information. Updated June 2025. Accessed June 26, 2025. https://pi.lilly.com/us/amyvid-uspi.pdf

4. Eli Lilly. Amyvid Beta-Amyloid Scan. Accessed June 26, 2025. https://amyvid.lilly.com/