FDA fast-tracks Life Molecular’s tau PET tracer

Life Molecular Imaging had secured fast-track designation from the U.S. Food and Drug Administration (FDA) for its new PET radiotracer for visualizing brain tau pathology associated with neurodegenerative diseases.

F-18 PI-2620 is currently in phase III clinical development for detecting tau pathology in Alzheimer's disease and is being investigated in other neurodegenerative diseases, Life Molecular said. Tau proteins are a hallmark of several neurodegenerative disorders including Alzheimer’s disease, progressive supranuclear palsy, corticobasal degeneration, and frontotemporal lobar dementia.

The ability to accurately image tau pathology could significantly enhance disease diagnosis and patient care, the company said.

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