MONTREAL, QC – Piramal Imaging SA and ISOLOGIC Innovative Radiopharmaceuticals report that Health Canada has issued a Notice of Compliance (NOC) for NeuraCeq (florbetaben F18 injection).
ISOLOGIC has received marketing authorization from Health Canada for the commercial production and market supply of NeuraCeq in Canada. NeuraCeq is the first diagnostic radiotracer to support the early diagnosis of Alzheimer’s disease that is commercially available in the country. It is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-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. NeuraCeq availability in Canada was previously limited 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 Dr. Jean-Paul Soucy, medical director of PET imaging at the Montreal Neurological Institute. “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.”
NeuraCeq has previously received approval from the FDA and several countries in EU and Asia, and is a diagnostic radiotracer that when used in combination with positron emission tomography (PET) imaging, can identify beta-amyloid plaques in the human brain, which are known as an important biomarker 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,” adds André Gagnon, president and CEO of ISOLOGIC. ” It could potentially help identify more efficacious interventions to help prevent, halt or slow down this terrible disease.”