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Wan LixinOpinion deputy editor of Shanghai Daily
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Alzheimer鈥檚 drug gets FDA nod
Print Edition
A NEW drug for Alzheimer’s disease developed by Chinese researchers has won approval from the US Food and Drug Administration to undergo clinical trials on patients overseas.
Green Valley Pharmaceutical Co, one of the drug’s co-developers, put the notice of FDA authorization to administer the drug to humans on its website on Sunday. The Shanghai Institute of Materia Medica under the Chinese Academy of Sciences confirmed yesterday in a statement.
The orally administered drug GV-971 was an achievement of a 22-year study led by researchers from the institute, Ocean University of China and Green Valley. According to an article published in the international journal Cell Research in September 2019, the drug, extracted from brown algae, works by modifying gut bacteria to ultimately reduce brain inflammation in mice that were genetically engineered to have the disease.
It was approved to market last November by China’s National Medical Products Administration, which said the drug “can improve cognition in patients with mild to moderate Alzheimer’s disease.”
“With clinical data on Chinese patents, Green Valley applied to the FDA for international multi-center trials and has received approval, which shortens the drug marketing process and brings new hope to more overseas AD patients,” the statement said.
The drug will be tested in 200 clinical centers in North America, the European Union, Eastern Europe, Asia Pacific and other places, said Green Valley, adding that the whole clinical research will skip the Phase 1, Phase 2 and go straight into the Phase 3 trial, the last test before reaching the market.
The FDA’s approval highlights the urgent need for an Alzheimer’s treatment, as well as the American regulator’s comfort with data recorded from clinical trials in China, according to a Bloomberg report. The company said it plans to complete the global clinical trials in 2024.
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