FDA sees potential in new PET imaging agent for cardiac amyloidosis
Attralus, a California-based biopharmaceutical company, has received the FDA’s breakthrough therapy designation for a new PET imaging agent designed to evaluate patients with suspected or known cardiac amyloidosis.
The drug, known as 124I-evuzamitide (AT-01), can be used to image “all types of systemic cardiac amyloidosis by PET/CT imaging.” Early clinical trials suggest it can detect different types of amyloid deposits, including ATTR and AL, in the heart, kidney, liver and spleen.
While cardiac amyloidosis is relatively rare, it can also be quite fatal. Being able to better image the disease is something radiologists and cardiologists alike have been looking forward to for quite some time.
“We are highly encouraged by FDA’s decision to grant breakthrough therapy designation to 124I-evuzamitide (AT-01), recognizing its potential as an innovative diagnostic agent for patients with systemic amyloidosis” Gregory Bell, MD, chief medical officer of Attralus, said in a statement. “There are no FDA-approved diagnostic imaging agents for cardiac amyloidosis. The diagnosis of cardiac amyloidosis is a challenging and time-consuming process for patients, with many going years without an accurate diagnosis, and losing critical time in the process. We remain committed to bringing 124I-evuzamitide to the market as quickly as possible and look forward to working more closely with FDA to bring 124I-evuzamitide to patients.”
The FDA uses its breakthrough therapy designation to speed up the approval process for medications “intended to treat a serious condition” after early evidence has suggested it may provide a significant improvement over the currently available treatment options. This is similar to how the agency uses its breakthrough device designation to accelerate approval for medical devices that show substantial potential. Drugs receiving breakthrough therapy designation automatically gain access to additional guidance from the FDA, including recommendations associated with the development process.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.