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pharmaphorum
Armed with new phase 3 data, Bayer is preparing to file for approval of a new PET imaging agent that could accelerate the diagnosis of diseases associated with the buildup of amyloid in the heart.
The REVEAL study of the radiotracer – iodine 234 evuzamitide (formerly AT-01) – met the criteria of both being able to identify patients with cardiac amyloidosis (sensitivity) and those without (specificity) based on visual interpretation of scans by a trained specialist.
The data from the trial, which was set up by clinicians at Brigham and Women's Hospital, will be presented at a future medical congress, and Bayer said it intends to discuss marketing applications with the FDA and other regulators.
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