A Chinese drugmaker has stunned the world with news that it has won conditional approval from the Chinese equivalent of the FDA to sell a new drug for Alzheimer’s disease -- the first approval of any new agent to treat Alzheimer’s since 2003.
in people, but it hasn’t been published in a peer-reviewed medical journal, where outside experts scrutinize and critique a paper before it’s presented to the public.published by the company Monday gave details of a phase 3 study, done in 34 hospitals in China, in 818 people with mild to moderate Alzheimer’s disease.
“The findings need to be replicated in order for this to be safely prescribed,” he says. What’s more, the benefits seen with the drug “were not that much different than what we’re seeing in drugs that are currently available in the marketplace,” including drugs likeSo while it is an interesting idea that you could turn down disease in the brain by changing bacteria in the gut, Ritter says far more study is needed to show that this medication works.
of Oligomannate that found the compound did not appear to perform better than a placebo. He also found a slide from the study, presented at a recent Chinese biomedical conference. The slide shows the group of patients taking the placebo saw a rapid and unexplained decline in how well their brains worked 6 months into the study. This sharp drop appears to drive most of the 2.54-point difference between the placebo and drug groups.
There were also questions about the company’s history. As noted in Lowe’s blog, Chinese journalists posted stories about another drug sold by the company, derived from a fungus, that had been marketed as a cancer cure. Lowe writes that the aggressive claims drew the attention of law enforcement and led to lawsuits from customers.
Chinese regulators will require the company to do more studies of the compound for safety. And Green Valley has promised to seek approval for its medicine in other countries. It pledged to do global clinical trials “in the near future.”
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