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FDA Approves Imaging Drug for Assessing Alzheimer’s Disease

June 05, 2020

The US Food and Drug Administration (FDA) has approved Tauvid (flortaucipir F18) for intravenous injection in adults with cognitive impairment who are being evaluated for Alzheimer’s disease.

Tauvid, a radioactive diagnostic agent from Avid Radiopharmaceuticals Inc., is indicated for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles, a primary marker of Alzheimer’s disease.

“This approval will provide healthcare professionals with a new type of brain scan to use in patients being evaluated for Alzheimer’s disease,” said Charles Ganley, MD, director of the Office of Specialty Medicine in FDA’s Center for Drug Evaluation and Research. “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.” 

Tauvid binds to sites in the brain associated with tau protein misfolding and can help identify the presence of tau pathology in PET scans. Imaging with Tauvid was evaluated in 2 clinical studies involving 5 evaluators blinded to clinical information.

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In the first, evaluators reading Tauvid images had a high probability of correctly evaluating patients with tau pathology, and had an average-to-high probability of correctly evaluating patients without tau pathology, in 64 terminally ill patients who participated in a post-mortem brain donation program.

In a second study that looked at reader agreement (in which perfect reader agreement would be 1 and no reader agreement would be 0), reader agreement was 0.87 across a total 241 patients. In a separate subgroup analysis of 82 terminally ill patients diagnosed after death and 159 patients with cognitive impairment, reader agreement was 0.90 for the patients with cognitive impairment and 0.82 in the terminally ill patients.

Because the studies included patients with more severe stages of dementia, Tauvid’s ability to detect tau pathology in patients in earlier stages of cognitive decline may be lower. The most common adverse reactions in patients using Tauvid were headache, injection site pain, and increased blood pressure.

—Jolynn Tumolo

Reference

FDA approves first drug to image tau pathology in patients being evaluated for Alzheimer’s disease [press release]. Silver Spring, Maryland: US Food and Drug Administration; May 28, 2020.

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