News | Contrast Media | June 01, 2020

The FDA has approved Lilly’s TAUVID (flortaucipir F 18 injection), a radioactive diagnostic agent, for PET imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease

The FDA has approved Lilly’s TAUVID (flortaucipir F 18 injection), a radioactive diagnostic agent, for PET imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease

Getty Images


June 1, 2020 — TAUVID, a radioactive diagnostic agent, has been approved by the FDA for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD). A neuropathological diagnosis of AD requires the demonstration of the presence of both beta-amyloid neuritic plaques and tau NFTs in the brain. TAUVID is the first and only approved diagnostic agent to image tau NFTs in the brain. Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Eli Lilly and Company, developed TAUVID and AMYVID (Florbetapir F 18 Injection) to provide physicians with meaningful information on the presence of both pathologies to aid the evaluation of patients suspected of having AD.

“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,” said Reisa Sperling, M.D., Professor of Neurology of Harvard Medical School, and Director of the Center for Alzheimer Research and Treatment at Brigham and Women's Hospital and Massachusetts General Hospital. “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.”

TAUVID was evaluated in two clinical studies. In Study 1, reader interpretations of premortem TAUVID scans from 64 cognitively normal and impaired terminally ill patients who agreed to undergo TAUVID imaging and 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. This study met its pre-specified success criteria, with reader sensitivity (95% CI) ranging from 92% (80, 97) to 100% (91, 100) and specificity (95% CI) from 52% (34, 70) to 92% (75, 98) in the primary efficacy cohort. In Study 2, images from the same terminally ill patients as in Study 1 (plus 18 additional terminally ill patients) and 159 patients with cognitive impairment being evaluated for AD (the indicated population) were evaluated by 5 new readers. This study also met the prespecified success criteria for comparison of TAUVID reads to NFT pathology. In addition, inter-reader agreement was evaluated using Fleiss’ kappa statistic and found to be 0.87 (95% CI: 0.83, 0.91) across 241 patients in Study 2. The most common adverse reactions reported in clinical trials were headache (1.4%), injection site pain (1.2%), and increased blood pressure (0.8%).

“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,” said Mark Mintun, M.D., vice president of Lilly’s pain and neurodegeneration research and development. “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. Lilly and Avid Radiopharmaceuticals are committed to bringing innovative AD diagnostics to the patients who need them most.”

Availability of TAUVID will initially be limited and will expand in response to commercial demand and payor reimbursement. Lilly remains committed to patients with cognitive impairment associated with Alzheimer’s disease and to ensuring patient access to this innovative diagnostic tool. Lilly is supportive of policies that will provide access and coverage for beta-amyloid PET and tau PET imaging agents.

For more than 30 years, Lilly has been engaged in bringing innovative Alzheimer’s disease therapies and diagnostics to patients and continues to lead the field in research, which also includes identifying biomarkers to support early detection of the disease.

For more information: www.lilly.com

Related Content

News | Nuclear Imaging

January 26, 2022 — On January 24, the Emergency Response Team (ERT) of Nuclear Medicine Europe (NMEu) communicated that ...

Time January 26, 2022
arrow
News | Nuclear Imaging

January 26, 2022 — IBA, a world leader in particle accelerator technology and the leading provider of ...

Time January 26, 2022
arrow
News | Prostate Cancer

January 24, 2022 — New research has confirmed the accuracy of the novel European Association of Urology (EAU) risk ...

Time January 24, 2022
arrow
Feature | Contrast Media Injectors | By Melinda Taschetta-Millane

Contrast media injectors are used to inject contrast agents to enhance the blood and perfusion in tissues. There have ...

Time January 19, 2022
arrow
News | Prostate Cancer

January 19, 2022 — For the first time, researchers led by a team from the UCLA Jonsson Comprehensive Cancer Center used ...

Time January 19, 2022
arrow
News | Lung Imaging

January 17, 2022 — A recent, substantial decline in lung cancer deaths is associated with earlier diagnosis of lung ...

Time January 17, 2022
arrow
News | Coronavirus (COVID-19)

January 17, 2022 — The Society of Nuclear Medicine and Molecular Imaging (SNMMI) issued a statement on Jan. 14 regarding ...

Time January 17, 2022
arrow
News | Radiation Therapy

January 13, 2022 — A new clinical guideline from the American Society for Radiation Oncology (ASTRO) provides guidance ...

Time January 13, 2022
arrow
News | PET-CT

January 12, 2022 — By combining information from two advanced imaging techniques with clinical data, physicians can ...

Time January 12, 2022
arrow
News | Radiology Imaging

January 12, 2022 — Machine-learning methods are being actively developed for computed imaging systems like magnetic ...

Time January 12, 2022
arrow
Subscribe Now