FDA grants AC Immune’s PI-2620 Tau-PET diagnostic fast track designations

AC Immune SA announced that its partner Life Molecular Imaging or LMI has received Fast Track Designation for the Tau positron emission tomography or PET diagnostic from the U.S. Food and Drug Administration FDA in three neurodegenerative conditions. Fast Track designation f has been granted for clinical development in Alzheimer’s disease AD , progressive supranuclear palsy PSP , and corticobasal degeneration CBD . The FDA’s Fast Track program is designed to accelerate the development and review of drugs that address serious conditions and fulfill unmet medical needs. This designation underscores the broadening view in the medical community that early and accurate diagnoses of neurodegenerative disease may lead to improved outcomes, thanks to emerging treatments. PI-2620 is a next-generation PET imaging agent currently in Phase 3 clinical development for detecting Tau pathology in Alzheimer’s disease. The compound is also being investigated in other neurodegenerative diseases by many academic researchers and in drug development trials. Tau proteins are a hallmark of several neurodegenerative disorders including AD, PSP, CBD, and frontotemporal lobar dementia, FTLD , and accurately imaging the pathology could significantly enhance disease diagnosis and improve patient care.