Alzheimer's (AD) diagnostic heavyweight! The first tau pathological imaging agent, Lilly Tauvid (flortaucipir F 18), is approved by the U.S. FDA!

May 30, 2020 /
Biovalley
BIOON/ --Lillyrecently announced that the U.SFood and Drug Administration (
FDA) has approved the Tauvid (
) Used for brain positron emission tomography (PET), a diagnosticagent for radiation, used in adult patients who are evaluating Alzheimer's (AD) with cognitive impairment to determine the density and distribution of brain-aggregator tau nerve fiber tangles (NFT)Neuropathological diagnosis ofAD needs to prove the presence of both beta amyloid sycatis plaques and tau-NFT plaques in the brainIt is worth noting that Tauvid is the first and only approveddiagnosticin the brain to image tau-NFT Avid Radiopharmaceuticals, a wholly owned subsidiary of Lilly , developed Tauvid and Amyvid (florbetapir F 18 injections) to provide doctors with meaningful information about the presence of two pathology strains to help assess patients suspected of having AD "Using diagnostic imaging, in addition to providing physicians with proper patient management, can help patients and their families make informed choices for the future and their health and well-being," said Dr 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 anatomical distribution of tau-NFT in the brain was previously only possible during autopsies Now we have a way to get this important information from patients "
Tauvid was evaluated in two clinical studies In Study 1, 64 cognitively normal and impaired end-stage patients agreed to receive Tauvid imaging and participate in the postmortem brain donation program, comparing the reader interpretation (reader interpretation ) to the tau pathology at the time of the autopsy (based on a rating from an independent pathologist who scand the results) The study met pre-specified success criteria, with reader sensitivity (95% CI) between 92% (80,97) and 100% (91,100) and specificity (95% CI) between 52% (34,70) and 92% (75,98) 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-stage patients) and 159 patients who were assessing AD with cognitive impairment (indicating population) The study also met the pre-specified success criteria for comparing Tauvid read with NFT pathology In addition, the fleiss'
app
a statistics assessed the consistency between readers of 241 patients in study 2 and found that the results were 0.87 (95% CI: 0.83, 0.91) The most common adverse reaction
s in clinical trial
were headache (1.4%), pain at the injection site (1.2%) and increased blood pressure (0.8%) "Combating AD requires an accurate and reliable assessment of the two key pathology of the disease, as only clinical evaluation is limited to the ability of patients to accurately diagnose ," said Mark Mintun, vice president of research and development for pain and neurodegenerative change at Lilly previous, The FDA has approved Amyvid to prove the presence of one of these two pathologies (beta amyloid plaques) I am very excited that Tauvid has now been approved for imaging tau-NFT, another key pathology that allows for a more comprehensive evaluation of patients lilies and Avid Radiopharmaceuticals are committed to providing innovative AD diagnostic for the patients most in need "
(biovalleybioon.com) original origin: Lilly Receives U.S.
FDA app roval of TAUVID ™ (flortaucipir F 18 injection) for Use in Patients Bei Evaluated for Alzheimer's Disease