Attralus’ 124I-Evuzamitide (AT-01) Gains the US FDA’s Breakthrough Therapy Designation for the Diagnosis of Cardiac Amyloidosis
Shots:
- The US FDA has granted BTD to the company’s non-invasive pan-amyloid PET imaging agent, 124I-evuzamitide (AT-01), intended for the diagnosis of cardiac amyloidosis. It has also been designated with the US FDA & EC’s ODD for ATTR & AL amyloidosis
- The designation was based on the results from Attralus-sponsored & investigator-initiated trials assessing 124I-evuzamitide among cardiac amyloidosis patients. Its P-III trial is expected during H1’25
- 124I-evuzamitide, labeled with iodine-124, is an amyloid-specific imaging agent intended to detect all kinds of systemic amyloidosis. It can identify amyloid deposits such as ATTR & AL, in organs like the heart, kidney, liver, and spleen as demonstrated in clinical evaluations
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.