Bayer's new imaging agent for cardiac amyloidosis impresses in clinical trial
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An investigational radiotracer developed by Bayer to improve the diagnosis of cardiac amyloidosis has met its primary endpoints in the third phase of an ongoing trial testing its safety and utility.
The REVEAL study has been assessing the sensitivity and specificity of iodine 124 evuzamitide (I 124 evuzamitide), a PET agent capable of visualizing signs of cardiac amyloidosis. The condition is owed to abnormal accumulations of amyloid deposits in the heart, which causes it to become stiff and rigid over time. Eventually, this can affect the heart’s rhythm and lead to heart failure when it progresses. It can be difficult, however, to diagnose.
Experts are hopeful the agent will help clinicians identify the condition sooner, allowing them to initiate treatment before the condition worsens.
“Cardiac amyloidosis is often under- or misdiagnosed, impacting patients’ ability to begin appropriate treatment earlier, when it may help prevent further organ damage,” REVEAL principal investigator Sharmila Dorbala, MD, MPH, director of nuclear cardiology at Brigham and Women’s Hospital, said in a news release. “These I 124 evuzamitide data demonstrate the potential of a single test to help healthcare providers identify or exclude cardiac amyloidosis."
The REVEAL study recruited a group of patients with suspected cardiac amyloidosis to undergo PET imaging after being injected with the radiotracer. Scans were conducted between three and five hours after participants were given the injection and were interpreted by a group of cardiac PET experts for sensitivity and specificity in identifying the condition. So far, the results indicate that the agent has yielded high marks for both metrics.
Following the results, Bayer now plans to prepare to submit the tracer for clearance from the U.S. Food and Drug Administration. Previously, the agent was granted Breakthrough Therapy Designation for PET imaging in patients with suspected or known cardiac amyloidosis, plus Orphan Drug status for both light-chain amyloidosis and transthyretin amyloidosis in the U.S. and Europe.
“We are very excited about the positive topline results of the REVEAL study and are looking forward to sharing the data with the scientific community," Konstanze Diefenbach, MD, head of radiology research and development in Bayer’s Pharmaceuticals Division, said in a statement.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.