CMI Inc. and Life Molecular Imaging Announce the Reimbursement of the Amyloid-PET Diagnostic Neuraceq® (florbetaben 18F) in Japan
First Reimbursed Amyloid PET Diagnostic Tool in
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.
After the recent approval of Eisai's Alzheimer's disease (AD) modifying drug LEQEMBI® in
"Achieving reimbursement for amyloid PET using Neuraceq® in
"LMI is committed to expanding global market access of Neuraceq®. We will continue to work with our partner CMI in
"CMI is intensively working for PET facilities in
For more information in Japanese, please read the CMI press release:
https://www.cmi-jpn.co.jp/wp-content/uploads/20231122PR.pdf
About Neuraceq Automated Synthesizer Synthera+® (florbetaben 18F)
Indication approved in the
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. 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
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
About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI, formerly Piramal Imaging) was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of
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SOURCE Life Molecular Imaging
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