Germany-based international pharma company Life Molecular Imaging (LMI) announced on Wednesday that it has received Fast Track Designation from the US Food and Drug Administration (FDA) for its [18F]PI-2620 Injection, an investigational PET imaging agent targeting tau neurofibrillary tangles.

The company has received the Fast Track designation for clinical development in Alzheimer's disease (AD), progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD).

Currently, [18F]PI-2620, a next-generation, F18-labeled PET imaging agent, is in Phase three clinical development for detecting tau pathology in Alzheimer's disease. The compound is also being evaluated in other neurodegenerative diseases and settings by various academic researchers and in drug development trials.

Andrew Stephens, LMI chief medical officer, said, '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. This designation not only validates our approach but also facilitates closer collaboration with the FDA to expedite the development of [18F]PI-2620. 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.'