Flortaucipir (aka F-T807) was discovered by the Siemens biomarker research group, headed by Hartmuth Kolb and Katrin Szardenings, who also conducted first in human trials. Flortaucipir (F) was approved for medical use in the United States in May 2020.
The safety and effectiveness of flortaucipir (F) imaging was evaluated in two clinical studies. In each study, five evaluators read and interpreted the flortaucipir (F) imaging. The evaluators were blinded to clinical information and interpreted the imaging as positive or negative.
The first study enrolled 156 participants who were terminally ill and agreed to undergo flortaucipir (F) imaging and participate in a post-mortem brain donation program. In 64 of the participants who died within nine months of the flortaucipir (F) brain scan, evaluators' reading of the flortaucipir (F) scan was compared to post-mortem readings from independent pathologists who evaluated the density and distribution of neurofibrillary tangles (NFTs) in the same brain. The study showed evaluators reading the flortaucipir (F) images had a high probability of correctly evaluating participants with tau pathology and had an average-to-high probability of correctly evaluating participants without tau pathology.
The second study included the same participants with terminal illness as the first study, plus 18 additional participants with terminal illness, and 159 participants with cognitive impairment being evaluated for Alzheimers disease (the indicated patient population). The study gauged how well flortaucipir (F) evaluators readings agreed with each other's assessments of the readings. Perfect reader agreement would be 1, while no reader agreement would be 0. In this study, reader agreement was 0.87 across all 241 participants. In a separate subgroup analysis that included the 82 terminally ill participants diagnosed after death and the 159 participants with cognitive impairment, reader agreement was 0.90 for the participants in the indicated population and 0.82 in the terminally ill participants.
The FDA approved flortaucipir (F) based on evidence of 1921 participants from 19 trials conducted at 322 sites in the United States, Australia, Belgium, Canada, France, Japan, Netherlands and Poland.
The ability of flortaucipir (F) to detect tau pathology was assessed in participants with generally severe stages of dementia and may be lower in participants in earlier stages of cognitive decline than in the participants with terminal illness who were studied.
The U.S. Food and Drug Administration (FDA) granted the application for flortaucipir (F) priority review and it granted approval of Tauvid to Avid Radiopharmaceuticals, Inc.