FDA Approves Flortaucipir F18 For Patients Being Evaluated for Alzheimer Disease

Officials from the FDA have approved flortaucipir F18 (Tauvid, Eli Lilly) for intravenous injection as the first drug used to help image a distinctive characteristic of Alzheimer disease in the brain called tau pathology.

Flortaucipir F18 is a radioactive diagnostic agent for adult patients with cognitive impairment who are being evaluated for Alzheimer disease. The drug is indicated for positron emission tomography imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFT), which is considered a primary marker of Alzheimer disease.

The approval is based on data from 2 clinical studies that evaluated the safety and effectiveness of flortaucipir F18, and where 5 evaluators read and interpreted the flortaucipir F18 imaging.

The first study enrolled 156 patients who were terminally ill and agreed to undergo imaging with flortaucipir F18 and participate in a post-mortem brain donation program. Sixty-four patients died within 9 months of the flortaucipir F18 scan, and the evaluators reading the flortaucipir scan compared the post-mortem readings from independent pathologists who evaluated the density and distribution of NFTs in the same brain.

The study found that evaluators reading the flortaucipir F18 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.

The second study included the same patients with terminal illness as the first study, plus 18 additional patients with terminal illness. The study evaluated 159 patients with cognitive impairment being evaluated for Alzheimer disease. In this study, reader agreement was 0.87 across all 241 patients, on a scale of perfect reader agreement at a 1, while no reader agreement would be a 0.

In a separate subgroup analysis that included the 82 terminally ill patients diagnosed after death and the 159 patients with cognitive impairment, reader agreement was 0.90 for the patients in the indicated population and 0.82 in the terminally ill patients.

Flortaucipir F18’s ability to detect tau pathology was assessed in patients with generally severe stages of dementia and may be lower in patients in earlier stages of cognitive decline than in patients with terminal illness who were studied.

The most common adverse reactions in patients using flortaucipir F18 were headache, injection site pain, and increased blood pressure.

REFERENCE

FDA approves first drug to image tau pathology in patients being evaluated for Alzheimer’s disease. FDA. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-image-tau-pathology-patients-being-evaluated-alzheimers-disease?utm_campaign=052820_PR_FDA%20Approves%20First%20Drug%20to%20Image%20Tau%20Pathology%20for%20Alzheimer%E2%80%99s%20Disease%20Evaluation&utm_medium=email&utm_source=Eloqua. Published May 28, 2020. Accessed May 29, 2020.