New tau imaging agent granted FDA's Fast Track designation

A new PET imaging agent that targets tau neurofibrillary tangles has been granted the U.S. Food and Drug Administration’s Fast Track designation. 

Berlin, Germany-based Life Molecular Imaging—an international pharma company that specializes in radiopharmaceuticals—made the announcement about its [18F]PI-2620 injection on Wednesday, noting that it is in clinical development for three different neurodegenerative conditions—Alzheimer’s disease, progressive supranuclear palsy and corticobasal degeneration. The investigational F18-labeled PET imaging agent is in Phase 3 trials testing its effectiveness at detecting tau pathology.  

Thus far, the agent has demonstrated promising brain uptake and fast wash-out in non-target regions and excellent reproducibility. Since there is no off-target binding associated with its use, [18F]PI-2620 is said to ably detect early signs of tau deposition in the brain.  

LMI Chief Medical Officer Andrew Stephens, MD, PhD, said that the agent’s Fast Track designation represents a “major milestone” for the company and “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,” Stephens said in an announcement on the designation. “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.” 

With the recent approval of multiple drugs that have been shown to slow the progression of Alzheimer’s, the demand for PET imaging to track treatments’ effectiveness will inevitably grow. In response to these developments, the Centers for Medicare and Medicaid services updated its coverage determination to include more frequent amyloid PET imaging to monitor patients’ treatment response.  

CMS’ expansion of coverage now allows for multiple scans and extends access to patients who are not involved in clinical trials. Coverage decisions related to the use of PET imaging for AD are now up to regional Medicare Administrative Contractors, or MACs. 

Learn more about the new PET agent here.