FDA grants fast track designation to PET tau imaging tracer

The FDA has granted fast track designation to a radioactive fluorinated positron emission tomography tracer for imaging tau protein in those with suspected progressive supranuclear palsy, according to the manufacturer.

APN-1607 was developed to quantify 3R and 4R tau aggregates by positron emission tomography (PET) for a range of tau-specific disorders, including Alzheimer’s disease, Aprinoia Therapeutics said in a press release. As such, APN-1607 may enable more accurate diagnosis at earlier disease stages, as there are no current FDA-approved diagnostic markers for the rare neurological condition.

Fast track designation allows for more rapid development and expeditious review of therapeutic candidates which may address an unmet medical need, with the goal of advancing novel diagnostic and treatment options to patients more quickly than traditional regulatory routes.

“APN-1607 is a unique imaging agent as it was designed to detect specific forms of tau implicated in [progressive supranuclear palsy] and other related disorders,” Brad Navia, MD, PhD, chief medical officer of Aprinoia Therapeutics, said in the release.

“If approved, APN-1607 would provide physicians with an important diagnostic tool that will allow them to diagnose PSP with greater confidence and differentiate it from other disorders, thereby improving the management of these patients.”