IBA, CMI and Life Molecular Imaging announce Japanese approval for the reimbursement of amyloid-PET diagnostic Neuraceq® in Alzheimer's disease
Wednesday, December 13rd, 2023
Louvain-la-Neuve, Belgium, December 13, 2023 – IBA (Ion Beam Applications S.A., EURONEXT), CMI Inc. and Life Molecular Imaging (LMI) are pleased to announce that the Japanese Ministry of Health has approved the reimbursement by governmental health insurance of the amyloid Positron Emission Tomography (PET) diagnostic Neuraceq® (florbetaben 18F).
Amyloid-PET imaging using agents like Neuraceq® is used in the diagnosis of Alzheimer's disease and other forms of cognitive impairment. It detects amyloid plaques in the brain, which are characteristic markers of Alzheimer's disease. With this approval, Neuraceq® is the first amyloid PET diagnostic tool reimbursed in Japan. Neuraceq® is produced with IBA’s Synthera®+, a fully automated synthesizer optimized for the production of florbetaben 18F.
With the reimbursement of this diagnostic tool, Japanese physicians can use this state-of-the-art imaging technology to accurately evaluate their patients with cognitive decline. The density of amyloid plaques can be assessed to improve an earlier diagnosis, and to further guide therapy and patient management.
Amyloid PET, including Neuraceq®, had a pivotal role in the recent positive clinical study outcomes of new anti-amyloid drugs by making selective inclusion of patients with confirmed amyloid pathology in the brain. Moreover, amyloid clearance was precisely measured with amyloid PET.
Bruno Scutnaire, President of IBA RadioPharma Solutions commented, “We are thrilled to join forces with these esteemed companies and celebrate this groundbreaking advancement in Alzheimer's disease diagnosis. We firmly believe this marks the initial stride towards establishing worldwide access to comprehensive care for this condition.”
Dr. Ludger Dinkelborg, Managing Director of Life Molecular Imaging added, “Achieving reimbursement for amyloid PET using Neuraceq® in Japan is a notable milestone. We are pleased that our amyloid PET tracer, a very important and reliable diagnostic imaging agent, is now available for more Japanese patients.”
Yasuhisa Fujibayashi, Chief Technology Officer, CMI Inc, commented, “CMI is intensively working for PET facilities in Japan and we are encouraging them to deliver amyloid-PET using Neuraceq® to patients with possible Alzheimer’s disease so that they may have an opportunity to access advanced therapeutic drugs.”
About Neuraceq® (florbetaben 18F)
Neuraceq® 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® is available in Japan from the approved medical device Synthera®+. A negative Neuraceq® scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq® scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq® is an adjunct to other diagnostic evaluations.
Limitations of Use
- A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder.
- Safety and effectiveness of Neuraceq® have not been established for (i) predicting development of dementia or other neurologic conditions, or (ii) monitoring responses to therapies.
Important Safety Information (as approved in Japan)
Risk for Image Interpretation and Other Errors
Errors may occur in the Neuraceq® estimation of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient's clinical information. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq® scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq® scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
Radiation Risk
Neuraceq®, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.
Common Adverse Reactions
The overall safety profile of Neuraceq® is based on data from 1,090 administrations of Neuraceq® to 872 subjects. Adverse Reactions occurring with a frequency of more than 1% include injection/application site erythema, injection site irritation and injection site pain.
For more information please visit: https://neuraceq.com