FDA Approves First Tau Pathology Drug
The US Food and Drug Administration (FDA) approved Tauvid (flortaucipir F18) for intravenous injection for the imaging of tau pathology among patients with cognitive impairment undergoing evaluation for Alzheimer disease. It is the first drug approved for this indication.
“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 Charles Ganley, MD, director of Office of Specialty Medicine in FDA’s Center for Drug Evaluation and Research, in a press release.
The most commonly reported adverse reactions associated with Tauvid use were injection site pain, injection site pain, and increased blood pressure. The FDA notes that Tauvid is not indicated for use in evaluating for chronic traumatic encephalopathy.
FDA approves first drug to image tau pathology in patients being evaluated for Alzheimer’s disease. News release. US Food and Drug Administration. May 28, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-image-tau-pathology-patients-being-evaluated-alzheimers-disease