The government on Friday approved the nation’s first diagnostic radiopharmaceutical agent Alzavue for Alzheimer’s disease, the fourth of its kind in the world, FutureChem, a drug developer, said.
According to the Ministry of Food and Drug Safety and FutureChem, Alzavue helps to diagnose dementia by imaging the presence or absence of beta-amyloid protein, which is considered to be the primary cause of dementia. Alzaview can be used in positron emission tomography (PET) scans.
The drug works as an assistant diagnostic agent for Alzheimer's disease or other causes of cognitive impairment in adults by showing the presence or absence of brain beta-amyloid neurons.
In 2008, FutureChem started working on precursors that target beta-amyloid. After eight years of research and development, the company completed the phase-3 clinical trials in 2016.
FutureChem applied for approval for Alzavue to the ministry in September 2016 and obtained the final nod on Friday.
Alzavue is cheaper than existing diagnostic imaging agents for Alzheimer’s disease, all of which are imported, and will help the company quickly penetrate the local market, FutureChem said.
The company also aims to grow Alzavue into a drug that helps the government make its slogan of the “state responsibility for dementia” a reality.
The government had announced measures to enhance the national health insurance coverage, vowing to radically lower the financial burden of dementia treatment on patients to 10 percent of the total cost. The government also said it would cover the cost of dementia diagnosis with health insurance.
“We’re preparing for global sales of radiopharmaceuticals, including Alzavue and PDvue, FutureChem CEO Chi Dae-yoon said. “This year will be the first year FuturChem enters the global market.”
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