SHANGHAI: A Chinese drugmaker has received approval from the Food and Drug Administration to start clinical trials in the US for a breakthrough Alzheimer’s drug as it seeks global validation for the controversial therapy.
FDA’s move to let Green Valley go straight to late-stage large-scale trials is a boost to its bid for global legitimacy after the experimental drug oligomannate received conditional approval in China late last year. It’s the first new medicine for the incurable neuro-degenerative disorder in nearly 17 years but there’s been skepticism from researchers over its unusual approach and efficacy.
The trial will be conducted for a year during which neither investigators nor patients will know who’s been given the medicine and who’s on placebo to avoid bias when interpreting results. This will be followed by six months of open study when all the patients will receive the drug.