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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).
The injectable (18F)PI-2620 agent, which is currently in a phase 3 trial for diagnosing tau pathology associated with Alzheimer’s disease, targets tau neurofibrillary tangles, according to Life Molecular Imaging, the developer of the PET agent.
Offering enhanced imaging of tau neurofibrillary tangles, the emerging PET agent (18F)PI-2620 has garnered fast track designation status from the FDA for detecting the progression of three neurodegenerative conditions including Alzheimer’s disease. (Images courtesy of Life Molecular Imaging.)
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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