FDA Approves First Drug for Imaging Tau Pathology in Alzheimer’s Disease

Tauvid (flortaucipir F18) was recently approved for intravenous injection during PET imaging of for patients being evaluated for Alzheimer’s disease after being granted Priority Review by the FDA. Tauvid is a radioactive diagnostic agent indicated for use during PET imaging to estimate the density and distribution of tau-associated neurofibrillary tangles (NFTs), which is a primary marker for Alzheimer’s disease.

Two proteins recognized as characteristic features of Alzheimer’s disease- tau and amyloid – are known for causing plaque deposits and NFTs in the brain tissue. Following injection of Tauvid, the drug binds to sites within the brain that are associated with pathological tau proteins, which can be visualized during a PET scan to identify the presence of tau pathology. Currently, Alzheimer’s disease can only be definitively diagnosed once the brain tissue has been evaluated postmortem. There are other imaging drugs approved for Alzheimer’s disease imaging for amyloid protein, however, these agents are only indicated after the patient has died. “Determining the anatomic distribution and density of tau NFTs in the brain was previously possible only at autopsy. Now we have a way to obtain this important information in patients.” Said Reisa Sperling, M.D., Professor of Neurology of Harvard Medical School, and Director of the Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital and Massachusetts General Hospital. “The use of diagnostic imaging can help patients and their families plan for the future and make informed choices about their health and well-being, in addition to facilitating appropriate patient management for physicians.”

Tauvid was evaluated in two clinical studies in which diagnostic interpretations using Tauvid were evaluated against autopsy interpretations in brain tissue postmortem. Tauvid’s ability to detect tau pathology was assessed in patients with generally severe stages of dementia and may be more difficult to assess in patients in earlier stages of cognitive decline than in the patients with terminal illness who were studied. The most common adverse reactions observed included headache, injection site pain, and increased blood pressure.

By: Jake Brassard, PharmD candidate 2021

For the full article, please visit https://www.todaysgeriatricmedicine.com/news/060920_news.shtml

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