Lilly Tauvaid (Flortaucipir F18) is approved by the FDA

Eli Lilly recently announced that the U.S. Food and Drug Administration (FDA) has approved Tauvid (Flortaucipir F 18 injection) for brain ect electron emission fault scanning (PET) imaging, a radiodiagnostic agent that is evaluating Alzheimer's (AD) adult patients with cognitive impairment to determine the density and distribution of brain aggregation tau nerve fiber tangle (NFT).The neuropathological diagnosis of AD requires proof of the presence of β amyloid neuritis plaques and tau-NFT in the brain. It is worth mentioning that Tauvid is the first and only approved diagnostic agent to image tau-NFT in the brain. Avid Radiopharmaceuticals, a wholly owned subsidiary of Lilly, has developed Tauvid and Amyvid (florbetapir F 18 injections) that will provide doctors with meaningful information about the presence of two pathology to help assess patients suspected of having AD."In addition to providing doctors with the right patient management, using diagnostic imaging can help patients and their families plan for the future and make informed choices about their health and well-being," said Reisa Sperling, M.D., a professor of neurology at Harvard Medical School and director of the Alzheimer's Research and Treatment Center at Massachusetts General Hospital and Brigham and Women's Hospital. Determining the distribution and density of tau-NFT in the brain was previously only possible during autopsies. Now we have a way to get this important information in patients. Tauvidin two clinical studies. In study 1, 64 patients with normal and impaired end-stage cognition agreed to undergo Tauvid imaging and participate in the post-mortem brain donation program, comparing reader interpretation from their pre-death Tauvid scans with tau pathology at the time of the autopsy (based on ratings provided by independent pathologists who blinded the scan results). The study met pre-specified success criteria, with reader sensitivity (95 percent CI) between 92 percent (80,97) and 100 percent (91,100) and specificity (95 percent CI) between 52 percent (34,70) and 92 percent (75,98 percent) in the main efficacy queue.In Study 2, five new readers evaluated images from the same end-stage patients in Study 1 (plus 18 additional end-of-life patients) and 159 patients with cognitive impairment (indicating population) who were evaluating AD. The study also met the pre-specified success criteria for comparing Tauvid read with NFT pathology. In addition, the reader-to-reader consistency of 241 patients in study 2 was evaluated using Fleiss'kappa statistics, and the results showed 0.87 (95% CI:0.83,0.91). The most common adverse reactions in clinical trials were headache (1.4%), pain at the injection site (1.2%) and elevated blood pressure (0.8%).Mark Mintun, Lilly's vice president of pain and neurodegenerative degeneration research and development, said: "The fight against AD requires an accurate and reliable assessment of the two key pathology of the disease, as clinical evaluation alone is limited in its ability to accurately diagnose patients. Previously, the FDA approved Amyvid to prove the presence of one of the two pathology β amyloid plaques. I am excited that Tauid has now been approved for imaging tau-NFT, another key pathology that allows for a more comprehensive assessment of patients. Lilly and Avid Radiopharmaceuticals are committed to providing innovative AD diagnostics to the patients who need it most. (Bio Valley Bioon .com)