Piramal Imaging SA and Isologic Innovative Radiopharmaceuticals have announced that a Notice of Compliance (NOC) from Health Canada has been issued to Isologic for NeuraCeq (florbetaben F18 injection).
The marketing authorization that has been issued from Health Canada will allow commercial production and market supply of NeuraCeq in Canada, the country's first commercially available diagnostic radiotracer to support the early diagnosis of Alzheimer’s disease (AD). The use was previously limited in Canada to investigational medicine purposes.
"The commercial availability of NeuraCeq will provide physicians throughout Canada a non-invasive method to more confidently and accurately assess complex and atypical cases of cognitively impaired patients for early diagnosis of Alzheimer's disease," said Doctor Jean-Paul Soucy, medical director of PET imaging at the Montreal Neurological Institute, in a statement. "In the absence of an approved disease modifying treatment, advancing our ability to make an early and accurate AD diagnosis is critically important to providing optimal symptomatic treatment and non-pharmacological measures to manage disease progression and quality of life in these patients."
When used in combination with PET imaging, the diagnostic radiotracer is able to identify beta-amyloid plaques in the human brain, which are key biomarkers for Alzheimer’s disease.
“In the context of evidence-based medicine, the introduction of NeuraCeq in the marketplace will offer a new clinical evaluation method for patients, physicians and caregivers alike in the diagnosis and management of Alzheimer's disease. It could potentially help identify more efficacious interventions to help prevent, halt or slow down this terrible disease,” said president and CEO of Isologic André Gagnon in a statement.