IBA, CMI and Life Molecular Imaging announce Japanese approval for the reimbursement of amyloid-PET diagnostic Neuraceq® in Alzheimer's disease
13 Dezembro 2023 - 3:00AM
IBA, CMI and Life Molecular Imaging announce Japanese approval for
the reimbursement of amyloid-PET diagnostic Neuraceq® in
Alzheimer's disease
Louvain-la-Neuve, Belgium, 13 December,
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.”
***ENDS***
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
ErrorsErrors 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 RiskNeuraceq®,
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 ReactionsThe
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 Bayer Pharma AG. It
is now part of the Life Healthcare Group. By developing novel PET
tracers for molecular imaging, LMI is focusing on a key field of
modern medicine. The organization strives to be a leader in the
Molecular Imaging field by developing innovative products that
improve early detection and characterization of chronic and
life-threatening diseases, leading to better therapeutic outcomes
and improved quality of life. Please visit https://life-mi.com.
About CMI Inc.
CMI Inc imports and sells highest quality
products such as cyclotron system, automatic PET drug synthesizer,
auto dispensing system and so on. CMI also supports planning,
development and operation of clinical as well as research
facilities for Positron Emission Tomography (PET) and contributes
to the progress and expansion of Japanese medical field. Learn more
at https://www.cmi-jpn.co.jp
About IBA
IBA (Ion Beam Applications S.A.) is the world
leader in particle accelerator technology. The company is the
leading supplier of equipment and services in the field of proton
therapy, considered to be the most advanced form of radiation
therapy available today. IBA is also a leading player in the fields
of industrial sterilization, radiopharmaceuticals and dosimetry.
The company, based in Louvain-la-Neuve, Belgium, employs
approximately 2,000 people worldwide. IBA is a certified B
Corporation (B Corp) meeting the highest standards of verified
social and environmental performance.
IBA is listed on the pan-European stock exchange
EURONEXT (IBA: Reuters IBAB.BR and Bloomberg IBAB.BB).
More information can be found at:
www.iba-worldwide.com
CONTACTS
IBASoumya
ChandramouliChief Financial Officer+32 10
475 890Investorrelations@iba-group.com
Olivier LechienCorporate
Communication Director+32 10 475 890communication@iba-group.com
ICR ConsiliumAmber Fennell,
Lucy Featherstone+44 (0) 20 3709 5700IBA@consilium-comms.com
Life Molecular
ImagingBrittany Hahn Marketing
Communications ManagerTel:
+1.484.735.2840
- 231213-Japan-Neuraceq-Reimbursment-approved_EN
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