PET Agent Gets FDA Fast Track Designation for Cardiac AL and ATTR Amyloidosis

The Food and Drug Administration (FDA) has granted fast track designation for potential use of the positron emission tomography (PET) agent 18^F(florbetaben) in the detection of cardiac amyloid light-chain (AL) and amyloid transthyretin-related (ATTR) amyloidosis.

Currently indicated for the estimation of beta amyloid neuritic plaque density on PET scans for patients being assessed for cognitive decline, 18F(florbetaben) (Neuraceq, Life Molecular Imaging) is currently the subject of a phase 3 multicenter trial for detection of cardiac amyloidosis, according to Life Molecular Imaging.

“Diagnosing cardiac AL amyloidosis is complex and challenging,” added Andrew Stephens, MD, PhD, CMO of Life Molecular Imaging. “(18^F)florbetaben PET imaging of patients with suspected cardiac amyloidosis has the potential to streamline the diagnostic process, providing earlier and appropriate access to therapy and improved monitoring of such interventions.”

Noting the safety profile of the radiopharmaceutical, Life Molecular Imaging said clinical trial research involving nearly 1,100 administrations of 18^F(florbetaben) revealed that the most common adverse drug reactions were injection site pain in 3.4 percent of patients and injection site erythema in 1.7 percent of patients.