The European Union’s Committee for Medicinal Products for Human Use (CHMP) today recommended the approval of Piramal Imagings' NeuraCeq (florbetaben 18F). The CHMP's recommendation will now be referred to the European Commission, for approval in the European Union (EU).
NeuraCeq is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of neuritic beta-amyloid plaque densityin the brainsof adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Piramal Imaging has partnered with IBA Molecular for manufacturing and distribution of NeuraCeq uponEU approval. IBA Molecular owns and operates a network of 54 PET isotope facilities worldwide, a network that is unique in both size and scope.
“This recommendation marks a major milestone for Piramal Imaging in our commitment to assist in the diagnosis of Alzheimer’s disease and the development of novel tracers for PET imaging. This is a key step towards making this innovative type of imaging more accessible to healthcare providers and patients across Europe,” said Dr Ludger Dinkelborg, director of the board, Piramal Imaging SA.
The CHMP’s positive opinion was based on data from the pivotal phase III autopsy study, which showed that PET imaging with NeuraCeqTM detects neuritic beta-amyloid in the brains of living subjects. The visual subject-level PET reading proposed for routine clinical practice compared to histopathology for the first 31 brains demonstrated 100 per cent sensitivity and 86 per cent specificity. In a post-hoc analysis in a larger population with 74 autopsied subjects, the sensitivity of the visual assessment was 98 per cent and specificity was 89 per cent.
It is important to note, that a positive Neuraceq scan does not establish a diagnosis of Alzheimer's disease or other cognitive disorder. Additionally, the safety and effectiveness of Neuraceq have not been established for predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.
According to Dr Swati Piramal, vice chairperson, Piramal Enterprises, “Alzheimer’s disease is a growing epidemic, with recent data suggesting more than six million people in Europe and 36 million people worldwide living with Alzheimer’s. When Piramal Enterprises acquired Bayer HealthCare's molecular-imaging pipeline in 2012, we were excited about the potential for NeuraCeq as an adjunct to other diagnostic evaluations for dementia. It arms physicians with additional data to help reduce misdiagnosis of Alzheimer’s disease and may have the potential to aid in earlier diagnosis and intervention. We look forward to hearing the European Commission’s final decision.”