Life Molecular Imaging Secures FDA Fast Track Designation for [18F]Florbetaben in Diagnosing Cardiac AL and ATTR Amyloidosis

• [18F]florbetaben has been granted a Fast Track designation for cardiac amyloidosis, which will expedite the development of [18F]florbetaben for this indication
• [18F]florbetaben previously received orphan drug status as a diagnostic for the management of AL amyloidosis in EU and US
• The efficacy of [18F]florbetaben in diagnosing cardiac amyloidosis is being evaluated in an ongoing multi-center Phase 3 study

BOSTON, Jan. 21, 2025 /PRNewswire/ -- 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.

"The FDA's Fast Track Designation is a pivotal achievement that highlights the potential of [18F]Florbetaben to address a critical gap in diagnosing cardiac AL and ATTR amyloidosis", said Dr. Ludger Dinkelborg, CEO of Life Molecular Imaging.

"Diagnosing cardiac AL amyloidosis is complex and challenging", added Dr. Andrew Stephens, MD, PhD, CMO of Life Molecular Imaging. "[18F]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."

About [18F]florbetaben
Neuraceq^® ([18F]florbetaben) is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. Neuraceq has been approved for routine clinical use in this indication by FDA, EMA and MHRA, and has local regulatory approval in other countries such as Canada, UK, Japan, China, Taiwan, and Korea. [18F]florbetaben 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.

Most Common Adverse Reactions
In clinical trials including demented and non-demented subjects, the most frequently observed adverse drug reactions in 872 subjects with 1090 Florbetaben (18F) administrations were injection/application site erythema (1.7%), injection site irritation (1.1%), and injection site pain (3.4%).

About Life Molecular Imaging (LMI) 
Life Molecular Imaging (LMI) is an international radiopharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field.  Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. LMI is an affiliate of Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, please visit https://life-mi.com.

About Life Healthcare Group
Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years' experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercializing innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases. Visit: https://www.lifehealthcare.co.za/. 

For media queries
Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging
Tel: +1.484.735.2840 | [email protected]

SOURCE Life Molecular Imaging