 has given Breakthrough Therapy Designation to a new imaging agent developed by Attralus, Inc., a company working on treatments for systemic amyloidosis){kind=link}
The U.S. Food and Drug Administration (FDA) has given Breakthrough Therapy Designation to a new imaging agent developed by Attralus, Inc., a company working on treatments for systemic amyloidosis. The agent, known as 124I-evuzamitide (AT-01), is intended for use in PET scans to help diagnose cardiac amyloidosis, a serious condition that can be difficult to detect.
This designation from the FDA is significant because it’s reserved for therapies that show promise in treating serious or life-threatening conditions, especially when they offer potential improvements over existing options. In this case, the FDA’s decision was based on clinical studies involving more than 200 people, which suggested that 124I-evuzamitide could be an important tool in diagnosing cardiac amyloidosis.
Cardiac amyloidosis occurs when abnormal proteins called amyloids build up in the heart, leading to serious health problems. It’s a condition that often goes undiagnosed for a long time because its symptoms are not specific, and there aren’t many diagnostic tools available. Currently, there are no FDA-approved imaging agents specifically for detecting this condition, making the development of 124I-evuzamitide noteworthy.
Dr. Gregory Bell, the Chief Medical Officer of Attralus, highlighted the importance of this development, stating that the new imaging agent could help doctors diagnose patients more quickly, potentially leading to earlier and better treatment options. “We’re focused on getting 124I-evuzamitide to patients as soon as we can,” Bell said.
124I-evuzamitide is designed to be a non-invasive way to spot amyloid deposits in key organs like the heart, kidneys, liver, and spleen. It has shown promise in clinical trials for detecting various forms of amyloidosis, which are rare diseases caused by these toxic protein buildups.
Attralus, based in Burlingame, California, is dedicated to finding better ways to treat systemic amyloidosis, aiming to develop therapies that can remove these harmful proteins and improve patients’ lives.