Germany-based Life Molecular Imaging GmbH (LMI) announced on Thursday that florbetaben (18F) has been granted orphan designation by the European Commission for the diagnosis of Transthyretin (ATTR) Amyloidosis.

Florbetaben (18F) was initially developed and approved for the detection of neuritic amyloid plaques in the brains of patients with cognitive decline. Preliminary data suggest that florbetaben (18F) may also detect and quantify ATTR amyloid deposits in the heart and other organs using positron emission tomography (PET) imaging, thereby supporting diagnosis of the condition.

The current multi-centre Phase 3 trial is intended to further validate florbetaben (18F)'s efficacy in the diagnosis of cardiac amyloidosis, including the ATTR subtype.

"The orphan drug designation for florbetaben (18F) will support our efforts to validate this tracer for the diagnosis of both AL and ATTR cardiac amyloidosis. With the approval of several new treatment options, especially for ATTR cardiac amyloidosis, fast and reliable diagnosis of the disease becomes even more important," said Andrew Stephens, MD, PhD, LMI's chief medical officer.