German pharmaceutical company Life Molecular Imaging (LMI) announced on Tuesday that it has received Fast Track Designation from the US Food and Drug Administration (FDA) for its [18F]florbetaben for the diagnosis of cardiac amyloid light-chain (AL) and amyloid transthyretin-related (ATTR) amyloidosis.

Fast Track Designation is intended to get important new drugs to patients sooner.

[18F]florbetaben Positron Emission Tomography (PET) is validated and approved to detect neuritic beta amyloid plaques in the brain and is available via a global supply network marketed as Neuraceq. [18F]florbetaben has demonstrated its capability to identify amyloid deposits in the heart, including AL and ATTR. These findings led to its Orphan Drug Designation by both the European Commission and the FDA in 2020 for diagnosis of AL amyloidosis. The current Phase 3 trial aims to further validate [18F]florbetaben's efficacy in the diagnosis of cardiac amyloidosis.

Neuraceq ([18F]florbetaben), a radioactive diagnostic agent, is indicated for PET imaging of the brain to evaluate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being assessed for Alzheimer's Disease (AD) and other causes of cognitive decline. It has been approved for routine clinical use in this indication by the FDA, European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA), and has local regulatory approval in other countries including Canada, Japan, China, Taiwan and Korea. The product is currently under investigation as a targeted radiopharmaceutical for the detection of amyloid deposits in the heart and other organs of patients with cardiac and systemic amyloidosis of AL and ATTR type.