On 28 May, the US Food and Drug Administration (FDA) approved flortaucipir for intravenous injection prior to positron emission tomography (PET) scanning of the brain. The flortaucipir tracer, which was developed by a wholly-owned subsidiary of Eli Lilly & Co, has been approved for assessing the quantity, localization and extent of Tau neurofibrillary tangles in the brains of people with suspected Alzheimer’s disease.
A 2018 Phase III study that included post-mortem evaluation confirmed the sensitivity and specificity of flortaucipir, a radioactive tracer that specifically binds to Tau within neurofibrillary tangles. Using PET scans to detect the presence of intravenously-delivered flortaucipir in the brain, study investigators were able to accurately identify individuals with cognitive impairment or dementia due to Alzheimer’s disease. Availability of flortaucipir will initially be limited but will expand in response to commercial and clinical demand. The press release can be found here: https://investor.lilly.com/news-releases/news-release-details/lilly-receives-us-fda-approval-tauvidtm-flortaucipir-f-18