Alzheimer's breakthrough? Not so fast — experts poke holes in data underlying China's surprise approval
No new drug has been approved for Alzheimer’s since 2003, and researchers endeavoring to change that have been greeted with a graveyard of failed therapies. So when Chinese regulators waved a treatment developed by an obscure biotech through to the market — albeit a conditional approval contingent upon confirmatory data — it makes sense that scientists who woke up to the news were more in doubt than in awe.
While several prominent Alzheimer’s experts threw their weight behind the seaweed-derived therapy, oligomannate (GV-971), others contacted by Endpoints News were much more skeptical. As Green Valley Pharma has yet to release full data of the single Phase III trial on which the decision was based, most are taking a wait-and-see stance while the company prepares to launch a second, global trial in early 2020.
Among the deluge of questions surrounding the surprise approval, two seem particularly crucial: Did Green Valley offer enough credible evidence to warrant an OK? And did the drug really work as the biotech claimed?
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