Piramal Imaging SA, a subsidiary of Piramal Enterprises, has received acceptance for [18 F]-florbetaben to amyloid PET imaging by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). The company aims admission of [18 F]-florbetaben beta for visual detection -amyloid plaques in the brain of adult patients suffering from cognitive impairment and the presence of Alzheimer's disease or other causative diseases to be investigated. [18 F]-florbetaben binds to beta-amyloid plaques in the human brain - they are regarded as a characteristic feature of Alzheimer's disease.
The diagnosis of Alzheimer's disease is currently based on intensive clinical studies, including in surveys of family history and personal medical history, physical and neurological examination, laboratory tests (eg: thyroid tests) and diagnostic imaging, such as using a computer tomography (CT) or magnetic resonance imaging (MRI). Nevertheless, a definitive diagnosis is possible only after death, by the detection of amyloid beta plaques and neurofibrillary bundles in autopsy material. Post-mortem studies for the detection of beta-amyloid deposits in the brain show that 10 to 30 per cent of wrong diagnoses based on clinical investigations. [18 F]-florbetaben is currently being investigated for its possible applications in the detection of beta-amyloid plaques in living persons with cognitive impairments.
The filing of the [18 F]-florbetaben dossier is based on a broad clinical trial program, which also includes a phase III registration trial. In this PET imaging data from the brain of living patients after the administration of [18 F compared] florbetaben with a post-mortem analysis of brain tissue. The visual evaluation, which is proposed for routine use in the clinic revealed for the method a sensitivity of 100 per cent and a specificity of 92 per cent and a very good agreement between the evaluating examiners (kappa = 0.88).
This study was the first, in the beta-amyloid deposits in the brain histopathological sections of diseased patients with the uptake of [18 F were correlated] florbetaben in the corresponding sample areas. The study was conducted to confirm that [18 F]-florbetaben binds to beta-amyloid in the various regions of the brain and is diagnostically useful to rule out Alzheimer's disease. In a subsequent study of 461 photos of phase I, II and III studies were evaluated again in order to show that the visual inspection method is reliable if it has been trained with an electronic training programme. (Kappa = 0.87).
Dr Ludger Dinkelborg, chairman of Piramal Imaging SA, Dehareng Renaud, CEO of IBA Molecular said, “The filing of the [18 F]-florbetaben dossier marks an important milestone in our clinical Alzheimer's research. [18 F]-florbetaben PET imaging may increase diagnostic confidence and so the currently used clinical methods for evaluating patients supplement with declining cognitive performance meaningful. You can contribute to patients and their families receive timely a reliable diagnosis and fulfills an important medical need. We also see the potential for our product [18 F]-florbetaben for early detection of Alzheimer's disease and facilitating specific treatment decisions.”
The two companies have signed an agreement in 2012 whereby IBA Molecular, the manufacture and distribution of [18 to take over F] florbetaben after admission in US and Europe. IBA Molecular owns and operates a global, unique in size and scope network of 54 plants for the production of PET isotopes. “We believe that our network is very well positioned to provide patients the best possible access to [18 to ensure F] florbetaben. We are strongly committed to our customers and their patients about this product with the highest quality and the best service get,” said Renaud Dehareng.
[18 F]-Florbetaben is an 18 F-labeled radiopharmaceutical for use in positron emission tomography (PET). It specifically binds to beta-amyloid deposits in the brain, a key pathological feature of Alzheimer's disease. A phase III clinical trial, which was first presented at the annual meeting of the American Academy of Neurology in 2012, showed that PET imaging with [18 F]-florbetaben in the situation is to detect beta-amyloid in the brains of living patients. A visual evaluation, as recommended for routine use in the clinic showed a sensitivity of 100 per cent and a specificity of 92 per cent.
In the field of molecular imaging Piramal Enterprises recently acquired the global rights to the research and development portfolio of Bayer AG and established Piramal Imaging SA. The acquisition of global rights includes the rights to [18 F]-florbetaben, a highly specialized molecules for PET detection of typical for Alzheimer's disease beta-amyloid plaques. Recently, a phase III trial with [was 18 F]-florbetaben successfully completed.