Updated on 8 June 2015
Previously, Neuraceq availability in Korea was limited to investigational medicine purposes
Singapore: Piramal Imaging SA and Ci-Co Healthcare has announced that the companies have received marketing authorization by the Ministry of Food and Drug Safety (MFDS) and the National Evidence-based Healthcare Collaborating Agency (NECA) for the commercial production and market supply of Neuraceq(florbetaben F18 injection) in Korea.
Neuraceq is the first diagnostic radiotracer to support the early diagnosis of Alzheimer's disease (AD) that is commercially available in the country.
This announcement follows approval from the New Health Technology Assessment (nHTA) and the Korean Dementia Association (KDA) earlier this year. Previously, Neuraceq availability in Korea was limited to investigational medicine purposes.
Neuraceq has received approval by the FDA and EMA 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.
"We are very pleased to bring this very important diagnostic imaging tool to new markets like Korea. Piramal Imaging is committed to expanding global market access to Neuraceq and we will continue to partner with local distributors and GMP manufacturers like Ci-Co Healthcare and DuChemBio in Korea to advance the detection of Alzheimer's disease for imaging and referring physicians across the world," said Dr Ludger Dinkelborg, Member of the Board, Piramal Imaging.