Olde Hornet
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Chinese Alzheimer’s Drug Gets U.S. Approval for Stateside Trial
https://www.msn.com/en-us/health/he...-trial/ar-BB13dbpY?li=BBnb7Kz&ocid=spartanntp
A Chinese drugmaker has received approval from the Food and Drug Administration to start clinical trials in the U.S. for a breakthrough Alzheimer’s drug as it seeks global validation for the controversial therapy.
Shanghai Green Valley Pharmaceutical Co. got clearance on April 8 for the U.S. part of a global trial that seeks to enroll more than 2,000 patients with mild-to-moderate Alzheimer’s across North America, Europe and Asia, according to a company statement Sunday.
The drugmaker, which didn’t disclose the size of U.S. 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 U.S. 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 neuro-degenerative disorder in nearly 17 years but there’s been skepticism from researchers over its unusual approach and efficacy.
https://www.msn.com/en-us/health/he...-trial/ar-BB13dbpY?li=BBnb7Kz&ocid=spartanntp
A Chinese drugmaker has received approval from the Food and Drug Administration to start clinical trials in the U.S. for a breakthrough Alzheimer’s drug as it seeks global validation for the controversial therapy.
Shanghai Green Valley Pharmaceutical Co. got clearance on April 8 for the U.S. part of a global trial that seeks to enroll more than 2,000 patients with mild-to-moderate Alzheimer’s across North America, Europe and Asia, according to a company statement Sunday.
The drugmaker, which didn’t disclose the size of U.S. 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 U.S. 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 neuro-degenerative disorder in nearly 17 years but there’s been skepticism from researchers over its unusual approach and efficacy.
