China OKS first Alzheimer’s drug in 17 years
BEIJING: China approved a drug to treat Alzheimer’s made by a Shanghai-based pharmaceutical company, the first new therapy endorsed for the disease in 17 years and a major breakthrough in the country’s push to become a leader in scientific research.
The National Medical Products Administration said on Saturday it granted conditional approval to Oligomannate. In trials, the drug statistically improved cognitive function in patients suffering from mild to moderate Alzheimer’s as early as week four, Shanghai Green Valley
Pharmaceuticals said in a statement.
The drug is slated to be available in China by the end of 2019, Green Valley said, and joins only a handful of Alzheimer’s-related therapies worldwide. There are currently no globally approved treatments to slow or stop the neuro-degenerative disease, which is the most common cause of dementia in the US and robs people of their ability to remember and to perform basic tasks.
Green Valley said it plans to apply for marketing authorisation in “selected countries following the China launch”. It will start global clinical trials early next year, with sites in the US, Europe and Asia.
Pharmaceutical companies around the world have spent billions of dollars over decades chasing a cure for Alzheimer’s, with little to show for their efforts. Last month, in another potential breakthrough, Cambridge, Massachusetts-based Biogen Inc said it would ask US regulators to approve an experimental therapy after new analysis of data from two failed trials showed promising results.
Green Valley’s drug is a low molecular acid oligosaccharide compound extracted from marine brown algae, according to the Chinese regulator’s statement.