Piramal Imaging gets nod for supply, prod of Neuraceq in Korea

Piramal Imaging today said it has received approval of South Korean authorities for production and market supply of Neuraceq, a radiotracer to support early diagnosis of Alzheimer's disease, in that country.
Neuraceq (florbetaben F18 injection) is the first diagnostic radiotracer to support the early diagnosis of Alzheimer's disease (AD). It is approved in the US, EU and Korea, the company said in a statement.
The company and South Korea-based Ci-Co Healthcare have received marketing authorisation by Ministry of Food and Drug Safety and National Evidence-based Healthcare Collaborating Agency for commercial production and market supply of Neuraceq in Korea, the statement said.

The 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 accurately assess cognitively impaired patients for early diagnosis of Alzheimer's disease," said Professor Park MY, Yeungnam University Medical Center.
"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," Piramal Imaging Member of the Board Dr Ludger Dinkelborg said.