Life Molecular Imaging (LMI), an international pharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to [18F]florbetaben for the diagnosis of cardiac amyloid light-chain (AL) and amyloid transthyretin-related (ATTR) amyloidosis.
Fast Track is an FDA process designed to facilitate the development and expeditious evaluation of drugs which are used to treat serious conditions and fill an unmet medical need. The purpose of Fast Track is to get important new drugs to patients earlier.
[18F]florbetaben 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 (NCT05184088) aims to further validate [18F]florbetaben’s efficacy in the diagnosis of cardiac amyloidosis.
