US approves Chinese drug maker Shanghai Green Valley’s Alzheimer’s therapy for large-scale clinical trials
- FDA’s move is a boost for Shanghai Green Valley after its experimental drug oligomannate received conditional approval in China late last year
- The market for Alzheimer’s drugs could worth as much as US$30 billion in the US alone, according to Sanford C. Bernstein estimates
A Chinese drug maker 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.
Shanghai Green Valley Pharmaceutical got clearance on April 8 for the US part of a global trial that seeks to enrol more than 2,000 patients with mild-to-moderate Alzheimer’s across North America, Europe and Asia, according to a company statement on Sunday.
The drug maker, which did not disclose the size of US trials and still needs permission from other countries, aims to file for FDA approval to sell the drug by 2025 after the trial concludes. The start of the US trial may be delayed by the coronavirus pandemic but will not impact its long-term timeline, said Li Jinhe, the company’s vice-president of global operations.
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 neurodegenerative disorder in nearly 17 years but there’s been scepticism from researchers over its unusual approach and efficacy.
Global drug makers have invested billions of dollars in over 190 experimental drugs to treat Alzheimer’s, which affects 10 million people in China and 5.8 million in the US, with little to show for it.