GE HealthCare’s Vizamyl gains broader FDA approval for quantitative Alzheimer’s imaging

USA—The U.S. Food and Drug Administration (FDA) has recently expanded the approved uses of GE HealthCare’s Vizamyl (flutemetamol F-18) PET imaging agent, enhancing its role in Alzheimer’s disease diagnosis and treatment monitoring.

Initially approved in 2013, Vizamyl is a radioactive injection used during PET brain scans to detect beta amyloid plaques—protein buildups linked to cognitive decline and Alzheimer’s disease.

Previously, the interpretation of these scans was largely subjective, relying on visual assessments by clinicians.

 However, the FDA’s new approval introduces quantitative analysis capabilities, allowing for objective, numerical measurement of amyloid levels in the brain through authorized software.

This advancement promises more consistent and reliable readings among healthcare providers.

Importantly, the FDA has also removed earlier restrictions on Vizamyl’s use in monitoring patient responses to anti-amyloid therapies.

This means clinicians can now better track how well treatments are reducing amyloid plaques and make informed decisions about when to stop therapy.

This is particularly valuable given the high cost and risks associated with anti-amyloid drugs like lecanemab and donanemab, which can cost tens of thousands of dollars annually and carry risks such as brain swelling.

The ability to objectively measure amyloid reduction helps ensure that only patients with sufficient plaque levels receive these therapies and that treatment is adjusted appropriately.

The updated label also broadens Vizamyl’s diagnostic scope. It now supports predicting cognitive decline and progression to dementia from early mild cognitive impairment stages and allows for Alzheimer’s diagnosis based on abnormal amyloid PET scans alone.

This aligns with recent criteria from the Alzheimer’s Association, recognizing amyloid PET positivity as sufficient for diagnosis.

The quantitative analysis is enabled by FDA-cleared software tools, such as GE HealthCare’s MIMneuro program, which scores amyloid plaque density on a scale from 0 to 100, with higher scores indicating a greater plaque burden, typical of Alzheimer’s patients.

GE HealthCare acquired the MIM Software division in April 2024 for approximately US$295 million, strengthening its capabilities in this niche diagnostic market.

This FDA label expansion positions Vizamyl uniquely among amyloid PET agents, as competitors like Lilly’s Amyvid and Piramal’s Neuraceq do not yet have approved indications for quantification or therapy monitoring.

The move is expected to boost GE HealthCare’s Pharmaceutical Diagnostics segment, which saw 9% growth in late 2024 and is projected to continue strong performance in 2025.

GE HealthCare’s broader portfolio also includes Flyrcado (flurpiridaz), an F-18 radiotracer approved for the treatment of coronary artery disease, which recently gained wide Medicare coverage.

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