Health
Taubid Obtains Tau Pathology Imaging Approval
Monday, June 1, 2020 (Health Day News)-The radioactive diagnostic agent, taubid (flortaucipir F18), has been approved to image tau pathology in cognitively impaired patients being evaluated for Alzheimer’s disease, The US Food and Drug Administration announced Thursday.
The drug is used in positron emission tomography (PET) imaging to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFT). Tauvid is delivered by intravenous injection and binds to brain regions associated with tau protein. Tau protein can be identified by PET scan imaging.
Approval was based on data from two clinical trials in which five blind assessors interpreted the Taubid image. In the first study, 156 end-stage patients agreed to undergo Tauvid imaging and participate in post-mortem brain donations. Among the 64 patients who died within 9 months of the brain scan, the researchers compared the Taubid scan results with postmortem measurements of independent pathologists assessing NFT density and distribution. .. The evaluators reading the Taubid image had a high probability of correctly assessing patients with tau lesions and a high average rate of correctly assessing patients without tau lesions.
The second study included the same 156 patients as in the first study, 18 end-stage illness patients and 159 patients with cognitive impairment, and the Taubid evaluator readings match on a scale of 0 to 1 Was found to be 0.87. In another subgroup analysis, the reader’s consent was 0.90 and 0.82, respectively, among 82 terminally diagnosed patients after death and 159 with cognitive impairment.
The most commonly reported side effects were headache, injection site pain, and elevated blood pressure. Taubid is contraindicated in patients with chronic traumatic encephalopathy.
Approval granted to Avid Radiopharmaceuticals.
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