The Food and Drug Administration (FDA) has approved Tauvid™ (flortaucipir F18; Lilly), a radioactive diagnostic agent, for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles in adult patients with cognitive impairment who are being evaluated for Alzheimer disease (AD).

The approval was based on 2 studies (Study 1 and Study 2) that evaluated the efficacy and safety of Tauvid imaging. Study 1 (N=156) included 64 terminally ill patients who agreed to participate in a post-mortem brain donation program. Study 2 included the same patients as the first study (plus 18 additional patients with terminal illness), and 159 patients with cognitive impairment being evaluated for Alzheimer disease. Each study had 5 evaluators read and interpret the Tauvid imaging.

Results from Study 1 demonstrated that Tauvid met the pre-specified success criteria with a reader sensitivity ranging from 92% (95% CI, 80-97) to 100% (95% CI, 91-100) and specificity ranging from 52% (95% CI, 34-70) to 92% (95% CI, 75-98). Findings from Study 2 showed that reader agreement was 0.87 (95% CI, 0.83-0.91) across all 241 patients with perfect reader agreement defined as 1. Additionally, reader agreement was 0.90 (95% CI, 0.85-0.95) among patients with cognitive impairment being evaluated for AD and 0.82 (95% CI, 0.75-0.88) in terminally ill patients.

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With regard to safety, the most common adverse reactions reported were headache, injection site pain and increased blood pressure. Tauvid is not indicated for use in the evaluation of patients for chronic traumatic encephalopathy. Healthcare professionals should consider additional evaluation to confirm AD in patients with a negative Tauvid scan.

“While there are FDA approved imaging drugs for amyloid pathology, this is the first drug approved for imaging tau pathology, one of the 2 neuropathological hallmarks of Alzheimer disease, and represents a major advance for patients with cognitive impairment being evaluated for the condition,” said Charles Ganley, MD, director of Office of Specialty Medicine in FDA’s Center for Drug Evaluation and Research.

The Company announced that it will initially provide a limited supply of Tauvid in 30mL and 50mL multiple-dose vials. Lilly’s other radioactive diagnostic agent, Amyvid (florbetapir F 18), is currently available for PET imaging of the brain to estimate β-amyloid neuritic plaque density in adults with cognitive impairment who are being evaluated for AD and other causes of cognitive decline.

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This article originally appeared on MPR