FDA Grants Fast Track Designation to Emerging Tau PET Imaging Agent

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.

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."