FDA approves Tauvid,a radioactive diagnostic agent, for PET imaging to evaluate Alzheimer's disease. Eli Lilly

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. 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%). 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. See - Fleisher AS, Pontecorvo MJ, Devous MD, et al. "Positron Emission Tomography Imaging With [18F]flortaucipir and Postmortem Assessment of Alzheimer Disease Neuropathologic Changes". JAMA Neurol. Published online April 27, 2020. doi:10.1001/jamaneurol.2020.0528.