Lilly Receives U.S. FDA Approval of TAUVID™ (flortaucipir F 18 injection) for Use in Patients Being Evaluated for Alzheimer's Disease
INDIANAPOLIS, May 28, 2020 /PRNewswire/ -- 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).1 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 (NYSE: LLY), 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.1,2
"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%).1,3
"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.
Indication and Important Safety Information for TAUVID
Limitations of Use
Important Safety Information
Warnings and Precautions
Risk of Misdiagnosis in Patients Evaluated for Alzheimer's disease
Negative TAUVID Scan
False Positive TAUVID Scan
Risk of Chronic Traumatic Encephalopathy Misdiagnosis
For Full Prescribing Information, visit http://pi.lilly.com/us/tauvid-uspi.pdf.
Indication and Important Safety Information for AMYVID
Limitations of Use
AMYVID is supplied in 30 mL or 50 mL multidose vials containing 500-1900 MBq/mL Florbetapir F 18.
Important Safety Information
Warnings and Precautions
Risk for Image Misinterpretation and other Errors
Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of AMYVID images has not been evaluated and may lead to errors. Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the AMYVID scan as well as motion artifacts that distort the image.
AMYVID scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future.
Most Common Adverse Reactions
For Full Prescribing Information, visit http://pi.lilly.com/us/amyvid-uspi.pdf.
About Avid Radiopharmaceuticals
About Eli Lilly and Company
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about TAUVID, a radioactive diagnostic agent indicated 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. This release reflects Lilly's current beliefs; however, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that the product will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
TAUVID™ is a trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
AMYVID® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
PP-FT-US-0001 05/2020 © Lilly LLC, USA. All rights reserved.
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