Approved: First Drug to Image Alzheimer’s Marker

(RxWiki News) The US Food and Drug Administration (FDA) has approved the first drug to help image tau pathology, a common marker in Alzheimer’s disease.

This approval is for Tauvid (flortaucipir F18). The FDA approved it for patients who are being evaluated for Alzheimer’s disease and those with cognitive impairment.

Like amyloid, tau is a marker for Alzheimer’s disease, so this new drug offers a new type of brain scan.

“While there are FDA-approved imaging drugs for amyloid pathology, this is the first drug approved for imaging tau pathology, one of the two neuropathological hallmarks of Alzheimer’s disease, and represents a major advance for patients with cognitive impairment being evaluated for the condition,” said Dr. Charles Ganley, director of the FDA’s Office of Specialty Medicine, in a press release.

In 2014, the Centers for Disease Control and Prevention (CDC) estimated that as many as 5 million people were living with Alzheimer’s disease in the US. To better understand why this new drug helps evaluate for Alzheimer’s disease, it is important to know what changes happen in the brain of someone who has Alzheimer’s disease.

Besides the presence of amyloid plaques, there are also neurofibrillary tangles (NFTs). These are abnormal accumulations of a protein called tau that collect inside neurons.

These tangles are what health care professionals look for when evaluating people for Alzheimer’s disease.

Injected into the vein, flortaucipir F18 is a radioactive diagnostic agent specifically to be used with positron emission tomography (PET) imaging.

Once injected, the flortaucipir F18 binds to areas in the brain where there is tau protein misfolding. The brain is then imaged with a PET scan, allowing doctors to look for tau pathology (specifically NFTs).

Two clinical studies evaluated this drug for its safety and effectiveness. Common side effects of Tauvid included headache, increased blood pressure and injection-site pain.

The approval of Tauvid was granted to Avid Radiopharmaceuticals, Inc.