FDA indicated TAUVID for PET imaging of brain to assess the density and distribution of NFTs in patients evaluated for Alzheimer's disease
Eli Lilly and Company's Corporate Center in Indianapolis, Indiana. (Credit: Momoneymoproblemz/Wikipedia.)
Eli Lilly (Lilly) has received the US Food and Drug Authority (FDA) approval for TAUVID, a radioactive diagnostic agent used for positron emission tomography (PET) imaging of the brain.
The diagnostic agent has been indicated for PET imaging of the brain to assess the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in cognitive impairment patients, evaluated for Alzheimer’s disease (AD).
TAUVID is counter-indicated for evaluation of patients for chronic traumatic encephalopathy (CTE).
Neuropathological diagnosis of AD requires the information of both beta-amyloid neuritic plaques and tau NFTs in the brain, and TAUVID marks the first and only approved diagnostic agent to image tau NFTs in the brain, said the company.
Avid Radiopharmaceuticals, a wholly-owned subsidiary of Lilly has developed TAUVID and AMYVID (Florbetapir F 18 Injection) to enable physicians to determine the presence of both pathologies to aid the evaluation of patients suspected of having AD.
Harvard Medical School professor of neurology Reisa Sperling said: “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.
“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.”
Lilly’s subsidiary Avid Radiopharmaceuticals is developing radioactive diagnostic agent TAUVID
TAUVID was evaluated in two clinical studies, Study 1 and Study 2.
In Study 1, premortem TAUVID scans from 64 cognitively normal and impaired terminally ill patients who agreed to participate in a postmortem brain donation program were compared to tau pathology at autopsy based on scoring provided by independent pathologists blinded to scan results.
The study has reached its pre-specified success criteria, with 92% to 100% reader sensitivity and 52% to 92% specificity in the primary efficacy cohort.
In Study 2, images from the same terminally ill patients studied in Study 1 and 159 patients with cognitive impairment under evaluation for AD were assessed by 5 new readers. The second clinical study has met the pre-specified success criteria for comparison of TAUVID reads to NFT pathology.
The company is planning for limited commercialisation of the TAUVID and intends to expand in response to commercial demand and payor reimbursement.
Lilly pain and neurodegeneration research and development vice president Mark Mintun said: “The fight against AD requires precise and reliable assessments of the two key pathologies of the disease because clinical assessments alone are limited in their ability to accurately diagnose patients.
“History was made with the FDA approval of AMYVID to demonstrate the presence of one of those two pathologies, beta-amyloid plaques. I am excited that TAUVID has now been approved to image tau NFTs, which is the other key pathology, allowing a more comprehensive evaluation of patients.”