Bayer REVEAL study hits primary endpoints for PET radiotracer in cardiac amyloidosis
Bayer said its Phase III REVEAL study of iodine-124 evuzamitide PET met primary sensitivity and specificity endpoints for diagnosing cardiac amyloidosis. Majority-read sensitivity was 94% and specificity was 86%.
Bayer Phase III REVEAL Study Meets Primary Endpoints in Cardiac Amyloidosis ⠀ · Bayer says the Phase III REVEAL study of investigational PET radiotracer iodine 124 evuzamitide met its primary endpoints for sensitivity and specificity in diagnosing cardiac amyloidosis. · Majority-read sensitivity was 94% and specificity was 86%; sensitivity was 96% for ATTR amyloidosis and 95% for AL amyloidosis. · Bayer plans to discuss the data and a potential regulatory submission with the FDA and other health authorities; iodine 124 evuzamitide is not currently approved in any country.