FDA Approves Imaging Drug for Assessing Alzheimer's Disease

The U.S. Food and Drug Administration (FDA) has cleared Avid Radiopharmaceuticals' imaging agent Tauvid for intravenous injection in adults with cognitive impairment who are being evaluated for Alzheimer's disease, reports Psychiatry & Behavioral Health Learning Network . Tauvid is indicated for positron emission tomography brain scans. "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 the FDA's Charles Ganley. Imaging with Tauvid was evaluated in two clinical studies, and in the first study evaluators had a high likelihood of correctly evaluating patients with tau pathology, and an average-to-high probability of correctly evaluating subjects without tau pathology in 64 terminally ill patients. The second study determined that reader agreement was 0.87 across a total 241 subjects, and 0.90 and 0.82 in respective subgroups of 82 terminally ill individuals diagnosed after death and 159 persons with cognitive impairment. The drug's ability to detect tau pathology in people in earlier stages of cognitive decline may be lower.