Attralus has received a breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for its PET radiotracer iodine-124 (I-124) evuzamitide (AT-01) for imaging cardiac amyloidosis.
The FDA granted the designation based on clinical data from Attralus-sponsored and investigator-initiated studies evaluating the use of I-124 evuzamitide PET in more than 200 trial participants, the company said.
Cardiac amyloidosis develops when amyloid proteins misfold and build up in the myocardium. This restricts cardiac function and can lead to heart failure and death. Currently, there are no FDA-approved diagnostic imaging agents for cardiac amyloidosis, Attralus noted.
![Pittsburgh Compound B (PiB) PET distribution volume ratio (DVR) images were projected onto fsaverage surfaces from FreeSurfer and surface smoothed, with PiB (amyloid) slope maps created using ordinary least squares regression (time as only factor) and mixed effects models for 154 participants run at each vertex (P < .01; model: longitudinal Geriatric Depression Scale score estimated by amyloid slope × time + [sex + education + age] × time). This map visualizes the results of the linear mixed-effects models (t score of the main variable, amyloid slope × time) such that regions with a greater t score (red) represent areas in which greater depressive symptoms are associated with greater amyloid accumulation (amyloid slope). Anatomical landmarks are provided: L refers to the left hemisphere, R refers to the right hemisphere, and additional labels indicate the anterior and posterior ends of the brain. Images available for republishing under Creative Commons license (CC BY 4.0 DEED, Attribution 4.0 International) and courtesy of JAMA Open Network.](https://img.auntminnie.com/files/base/smg/all/image/2024/08/PET_depression.66cf997f7e441.png?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
