FDA fast-tracks Life Molecular’s amyloid PET tracer

Life Molecular Imaging has secured fast-track designation from the U.S. Food and Drug Administration (FDA) for its amyloid PET radiotracer for visualizing cardiac amyloid light-chain (AL) and amyloid transthyretin-related (ATTR) amyloidosis.

F-18 florbetaben (Neuraceq) is already approved in the U.S. and Europe and is widely used to diagnose patients with Alzheimer’s disease based on amyloid deposits in the brain. Further evidence has demonstrated the radiotracer can detect deposits in the heart involved in AL and ATTR amyloidosis, the company said.

Life Molecular is currently validating F-18 florbetaben for diagnosing cardiac amyloidosis in a phase III trial after receiving Orphan Drug Designation by both the European Commission and the FDA for the indication in 2020, the company said.