FDA Grants Fast Track Designation to Emerging Tau PET Imaging Agent
Targeting tau neurofibrillary tangles, the (18F)PI-2620 agent reportedly provides promising insight into the development of three neurodegenerative conditions including Alzheimer’s disease.
A new tau positron emission tomography (PET) imaging agent that may facilitate diagnostic insights into the development of Alzheimer’s disease, progressive supranuclear palsy and corticobasal degeneration has garnered a fast track designation from the Food and Drug Administration (FDA).
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Emphasizing the (18F)PI-2620 agent’s combination of “robust” uptake in the brain and rapid wash-out in non-targeted brain regions, Life Molecular Imaging said the agent facilitates early detection and quantification of tau deposition in the brain.
"Receiving fast track designation from the FDA is a major milestone that highlights the promise of (18F)PI-2620 in addressing the critical need for effective diagnostic tools in Alzheimer's disease, progressive supranuclear palsy, and corticobasal degeneration," said Andrew Stephens, the chief medical officer at Life Molecular Imaging. " … We are committed to advancing this important imaging agent with the potential to make a meaningful difference for patients who need accurate and accessible tau PET imaging."
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