FDA OKs GE HealthCare’s Vizamyl PET Imaging Agent for Beta Amyloid Detection

GE HealthCare revealed the U.S. Food and Drug Administration (FDA) approved an updated label for its positron emission tomography (PET) imaging agent Vizamyl (flutemetamol F 18 injection) for beta-amyloid detection.

The revised label allows quantitative analysis of Vizamyl scans, and removes significant previous limitations like monitoring patient response to anti-amyloid therapy. With quantification added to the label, clinicians can reach an objective assessment using software that helps calculate amyloid load. Vizamyl can also now be used to evaluate whether the level of amyloid plaques has been reduced sufficiently for the therapy to potentially be stopped.

The update also adds an indication to select patients eligible for therapy and removes several previous limitations for use. This includes the diagnosis of Alzheimer’s, based on revised criteria from the Alzheimer’s Association, indicating that an abnormal amyloid PET scan is sufficient to establish a diagnosis.

The label also removes a limitation on predicting the cognitive decline or progression to dementia, based on evidence linking amyloid-positive scans to a higher risk of progression from the early mild cognitive impairment phase of Alzheimer’s dementia.

“The inclusion of quantification and removal of the therapy monitoring limitation from the Vizamyl label is good news for healthcare providers and their patients, further enabling timely and appropriate care decisions,” said Jit Saini, MD, Chief Medical Officer of the Pharmaceutical Diagnostics (PDx) division of GE HealthCare. “These changes pave the way for clinicians to expand their usage of Vizamyl, with meaningful implications for patients and their families— helping provide clearer answers, earlier diagnoses, and enabling more personalized treatment strategies.”

“The use of quantification in amyloid PET imaging has steadily moved from research to clinical practice, where it can aid in more confident and accurate diagnosis,” said Phillip Kuo, MD, Ph.D., FACR, Professor of Radiology, Section Chief of Nuclear Medicine and Director Theranostics at City of Hope National Medical Center. “Now quantification can also play a critical role in initiating and monitoring amyloid-targeted therapy for Alzheimer’s disease and determining when it can be discontinued.”

Earlier this month, the company launched the bkActiv S series of intraoperative ultrasounds. Part of the bkPortfolio of Active Imaging systems, bkActive S series ultrasounds are meant for interventional guidance during urology, colorectal, and pelvic floor procedures.