Attralus Granted Breakthrough Therapy Designation for 124I-evuzamitide in Cardiac Amyloidosis
Attralus, announced that its investigational diagnostic imaging agent, 124I-evuzamitide (AT-01), has received Breakthrough Therapy Designation (BTD) from U.S. FDA for positron emission tomography (PET) imaging in patients suspected of or diagnosed with cardiac amyloidosis.
This marks a significant milestone as 124I-evuzamitide is the only diagnostic imaging agent to achieve BTD specifically for cardiac amyloidosis. 124I-evuzamitide has received orphan drug designations from both the FDA and the European Commission for the management of ATTR and AL amyloidosis.
BTD is a programme designed to accelerate the development and review of products intended to treat or diagnose serious conditions when preliminary evidence suggests that the product may significantly improve on existing therapies.
Systemic amyloidosis consists of a group of rare diseases caused by the accumulation of harmful amyloid deposits in tissues and organs due to protein misfolding. These diseases can be progressive, debilitating, and often fatal, with cardiac involvement in the majority of patients. Current diagnostics for cardiac amyloidosis are limited, leading to significant delays in accurate diagnosis for many patients.
124I-evuzamitide (AT-01) is the inaugural non-invasive PET imaging agent targeting amyloid deposits, specifically developed for the diagnosis of systemic amyloidosis. It employs a pan-amyloid binding peptide labelled with iodine-124 to identify various forms of amyloid deposits across major organs, including the heart, kidneys, liver, and spleen. The compound aims to address the unmet need for improved diagnostics in the early detection of cardiac amyloidosis.
