- FDA approves updated label for GE HealthCare's Vizamyl PET imaging agent, enhancing Alzheimer's detection and monitoring.
- New label includes amyloid load quantification and allows monitoring therapy effectiveness.
- Vizamyl (GEHC, Financial) can now help predict Alzheimer's-related dementia and cognitive decline.
The U.S. Food and Drug Administration has approved a new label for GE HealthCare's (GEHC) positron emission tomography (PET) imaging agent, VizamylTM (flutemetamol F 18 injection). This update significantly expands its use for detecting beta amyloid deposits in the brain, a hallmark of Alzheimer’s Disease. This development allows a quantitative analysis of amyloid levels, enhancing the diagnostic accuracy and consistency of readings.
Previously, clinicians used Vizamyl mainly for visual assessment of amyloid plaque buildup. The inclusion of quantification now permits a more continuous and objective measure of amyloid in the brain, allowing healthcare providers to assess the effectiveness of anti-amyloid therapies and to predict when treatment might be halted. This update also enables the use of Vizamyl for evaluating patients at risk of progressing from mild cognitive impairment to Alzheimer’s-related dementia.
Dr. Jit Saini, Chief Medical Officer of GE HealthCare's Pharmaceutical Diagnostics division, stated that this change is a substantial advancement for healthcare providers and patients, facilitating improved care decisions. Additionally, Dr. Phillip Kuo, a leading expert in nuclear medicine, emphasized the critical role of quantification in clinical settings, enabling accurate monitoring of amyloid-targeted treatments.
GE HealthCare's recent FDA label update also aligns with revised criteria from the Alzheimer's Association, which recognizes abnormal amyloid PET scans as sufficient for diagnosing Alzheimer's Disease. This decision reflects a shift towards more precise and timely Alzheimer's care, benefiting patients and their families with earlier and more personalized treatment strategies.
