The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the amyloid radiotracer florbetaben 18F (NeuraCeq, Piramal Imaging GmbH) for Alzheimer's diagnosis.
"NeuraCeq is a radiopharmaceutical indicated for positron emission tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment," the CHMP said in a statement.
"The benefits with NeuraCeq are its ability to estimate beta-amyloid deposition, and therefore contribute with additional information to the clinical diagnostic process in Alzheimer's disease," the Committee noted.
Florbetaben PET imaging should be used in conjunction with a clinical evaluation, and images "should only be interpreted by readers trained in the interpretation of PET images with florbetaben (18F)," the Committee advised.
The most common adverse effects with the product are injection site reactions, such as irritation and pain.
On the basis of quality, safety, and efficacy data, the CHMP concluded that there is a "favorable benefit-to-risk balance for NeuraCeq and therefore recommended granting of the marketing authorization."
The CHMP's recommendation will now be referred to the European Commission for approval in the European Union.
Detailed recommendations for the use of NeuraCeq will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.
A pharmacovigilance plan for NeuraCeq will be implemented as part of the marketing authorization.
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Cite this: CHMP Backs PET Amyloid Tracer Florbetaben - Medscape - Dec 20, 2013.