The US Food and Drug Administration (FDA) has expanded the indications of an imaging agent developed by GE HealthCare, which will likely put it at the forefront of the Alzheimer鈥檚 diagnostics arena.
The updated label for GE HealthCare鈥檚 positron emission tomography (PET) imaging agent Vizamyl (flutemetamol F 18 injection) now includes quantification of amyloid in the brain, meaning patients taking an anti-amyloid therapy can be monitored for the drug鈥檚 effectiveness.
There are currently two anti-amyloid therapies approved in the US, namely Eisai/Biogen鈥檚 Leqembi (lecanemab) and Eli Lilly鈥檚 Kisunla (donanemab). Despite reimbursement challenges for the two drugs, revenue for them is expected to surge in the coming decade. However, patients seeking to take them must meet stringent criteria, and the therapy鈥檚 ongoing use comes with caveats 鈥� all of which must be diagnostically monitored with PET imaging.
City of Hope National Medical Center’s radiology professor Phillip Kuo said: 鈥淭he 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.
鈥淣ow 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.鈥�
Vizamyl was first approved in 2013 to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment. Now, visual estimation has turned into quantification, opening further diagnostic avenues for the imaging agent in Alzheimer鈥檚.
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By GlobalDataIn another boost for patients, the label update also adds an explicit indication for the selection of patients eligible for therapy. Effectively, the expansion now allows for the diagnosis of Alzheimer鈥檚. This has been based on revised criteria from the Alzheimer鈥檚 Association, indicating that an abnormal amyloid PET scan is sufficient to establish a diagnosis.
The updated label also removes a previous restriction on predicting cognitive decline or progression to dementia, reflecting new evidence that links amyloid-positive scans with a higher risk of advancing from early mild cognitive impairment to Alzheimer鈥檚 dementia.
Whilst there are other available amyloid diagnostics such as Lilly鈥檚 Amyvid (florbetapir), these do not have the same current range of label indications as Vizamyl.
GE HealthCare also has some of the most advanced PET devices on the market. According to analysis by GlobalData, the company has the largest global market share of nuclear imaging equipment, of which PET scanners are a segment.
鈥淭he 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,鈥� said GE HealthCare鈥檚 pharmaceutical diagnostics division鈥檚 chief medical officer Jit Saini.
Research into Alzheimer鈥檚 diagnosis is gaining momentum amid the revenue ceiling for anti-amyloid therapies. Last month, the , the to help diagnose the disease. The agency said the new tool could help reduce the number of PET scans, which are expensive and radiation-exposing. Developed by Fujirebio Diagnostics, the test measures the ratio between tau and amyloid proteins in the blood and ties its findings to the likelihood of finding plaque buildups in the brain.
