FDA Approves Tauvid as First Tau Protein Tracer Tool for Alzheimer’s Diagnosis

FDA Approves Tauvid as First Tau Protein Tracer Tool for Alzheimer’s Diagnosis
The U.S. Food and Drug Administration (FDA) has approved Tauvid (flortaucipir F18) as an imaging radiotracer agent — a radioactive diagnostic tool — to efficiently detect clumps of tau protein in the brain, one of the hallmarks of Alzheimer’s disease. “Alzheimer’s disease is a devastating condition that affects millions of Americans. This approval will provide health care professionals with a new type of brain scan to use in patients being evaluated for Alzheimer’s disease,” Charles Ganley, MD, director of the office of specialty medicine in the FDA’s Center for Drug Evaluation and Research, said in a press release. Tauvid, which was approved under the FDA’s priority review designation, is the first imaging agent cleared for use in detecting tau-related damage. In patients with Alzheimer’s, tau proteins misfold in the brain, creating neurofibrillary tangles. This new agent will detect these tangles, and aid in the diagnosis of Alzheimer’s in adults with cognitive impairments. Tracing agents had previously only been approved for the detection, after death, of amyloid-beta protein clumps, another hallmark of Alzheimer’s. The amyloid-beta clumps, or plaques, accumulate between nerve cells in the
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