What is Neuraceq - florbetaben used for?
Neuraceq is a solution for injection containing the active substance florbetaben (18F); it is a medicine for diagnostic use only. Neuraceq is used in the brain spectroscopic technique in patients with memory disorders, to allow doctors to detect the presence or absence of significant amounts of β-amyloid plaques in the brain. Β-amyloid plaques are deposits sometimes present in the brains of people with memory problems caused by dementia (such as Alzheimer's disease, Lewy body dementia and Parkinson's disease) as well as in the brains of some symptom-free seniors. The spectroscopic technique used with Neuraceq is called positron emission tomography (PET).
How is Neuraceq - florbetaben used?
Neuraceq can only be obtained with a prescription and PET scans with Neuraceq should only be requested by physicians experienced in managing patients with degenerative diseases such as Alzheimer's disease. The medicine is given by injection into a vein about 90 minutes before acquiring a PET image. The acquired image is examined by physicians specially trained to interpret PET scans with Neuraceq. Patients should discuss the results of the PET exam with their doctor.
How does Neuraceq - florbetaben work?
The active ingredient in Neuraceq, florbetaben (18F), is a type of medicine known as a radiopharmaceutical, which emits low amounts of radiation and works by binding to β-amyloid plaques in the brain. After attaching to the plates, it emits a radiation that can be detected at the PET exam, allowing doctors to know whether or not a significant number of plaques are present. If the PET scan shows few plaques or no β-amyloid plaque (negative scan), it is unlikely that the patient is affected by Alzheimer's disease. However, a positive scan by itself is not sufficient to make a diagnosis in patients with memory disorders, since the presence of plaques is observed in various types of degenerative diseases as well as in some elderly without symptoms. Doctors will then have to interpret the scans in the light of a clinical evaluation.
What benefit has Neuraceq - florbetaben shown during the studies?
Neuraceq was examined in a main study involving 216 volunteers, divided into two groups: a group of healthy young people and a group of very old patients, who had allowed autopsy after death; 41 volunteers (10 healthy young people and 31 patients) completed the study and were included in the results. The study examined the sensitivity and specificity of PET scans (ie the accuracy of such scans in identifying plaque-level volunteers and the accuracy in distinguishing such subjects with plaque-free patients). PET scans with Neuraceq have proven to be highly specific and sensitive in identifying patients with significant amounts of β-amyloid plaques in the brain. At the end of the study, 31 patients had died and autopsies had been conducted to detect the presence or absence of significant amounts of β-amyloid plaques in the brain. Comparing the results of autopsies with PET scans showed a sensitivity of the scans of 77.4% and a specificity of 94.2%. This means that PET scans were able to correctly identify as positive 77.4% of patients with significant amounts of plaques and that almost all subjects without significant plaques were correctly referred to as negative. These data were further confirmed by the results of new patients, analyzed at the end of the study.
What is the risk associated with Neuraceq - florbetaben?
The most common side effects with Neuraceq (which may affect up to 1 in 10 people) are pain and irritation at the injection site. For the full list of all side effects and restrictions with Neuraceq, see the package leaflet. Neuraceq releases a very low amount of radiation, with minimal risk of cancer or hereditary abnormalities.
Why has Neuraceq - florbetaben been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Neuraceq's benefits are greater than its risks and recommended that it be approved for use in the EU. The results of the main study showed that the PET scans acquired with Neuraceq detected the presence of β-amyloid plaques in the brain with a high sensitivity and specificity, so the results of the scans provided information similar to those obtained at autopsy . This is considered a significant improvement in diagnostic performance in patients with memory disorders that are evaluated for Alzheimer's disease and other types of degenerative diseases. However, there is still a risk of false positive results and, consequently, Neuraceq should not be used as the sole diagnostic method for degenerative diseases, but should be used in conjunction with clinical evaluation. The safety profile of Neuraceq was considered reassuring and the most common adverse effects were identified in terms of reactions at the injection site.
However, the CHMP noted that due to the limited effects of the currently available treatments for Alzheimer's disease, there is no robust evidence that an early diagnosis due to the acquisition of PET scans with Neuraceq and an early management of the therapy improve the prognosis for the patient. Furthermore, the usefulness of Neuraceq in predicting the development of Alzheimer's disease in patients with memory disorders or in monitoring patients' response to therapy has not been demonstrated
What measures are being taken to ensure the safe and effective use of Neuraceq - florbetaben?
A risk management plan has been developed to ensure that Neuraceq is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Neuraceq, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
Other information on Neuraceq - florbetaben
On February 20, 2014, the European Commission issued a marketing authorization for Neuraceq, valid throughout the European Union. For more information about treatment with Neuraceq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 02-2014
