Neuraceq is the first diagnostic radiotracer to support the early diagnosis of Alzheimer’s disease (AD) that is commercially available in the country
Piramal Imaging SA and Ci-Co Healthcare announced that the companies have received marketing authorisation 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.
“The commercial availability of Neuraceq will provide physicians throughout Korea with a non-invasive method to more confidently and accurately assess cognitively impaired patients for early diagnosis of Alzheimer’s disease,” said Professor Park MY, Yeungnam University Medical Center and Chairman of the KDA. “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 adequate symptomatic treatment and non-pharmacological measures to manage disease progression and quality of life of these patients.”
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,” said Dr Ludger Dinkelborg, Member of the Board, Piramal Imaging. “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,” he added.
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