Green Valley Pharma's new Alzheimer's drug GV-971 gets FDA approval for clinical trials in the U.S.

Green Valley Pharmaceuticals' controversial new Alzheimer's drug, the Glynette Sodium Capsule (GV-971), has been approved by the FDA for clinical trials in the United StatesGV971 was approved last year by the National Drug Administration (NMPA) for the treatment of mild to moderate Alzheimer's disease, becoming the first new drug to be approved for the disease since The United StatesGreen Valley Pharmaceuticals said it would conduct a global clinical trial of GV971, which will recruit 2,000 patients in the United States, Europe and Asia, after receiving FDA approvalThe results of the study from Green Valley Pharmaceuticals showed that in patients with mild to moderate Alzheimer's disease, oral GV971 was taken twice a day for 36 consecutive weeks, with a statistically significant improvement over the placebo in the ADAS-Cog 12 score for cognitive functionAt the end of the study, the average difference between GV-971 and placebo on that score was 2.54The three-point decline in the scale is considered to be a significant clinical deterioration of Alzheimer's diseasethe drug failed to improve the CIBIC-Plus score for dementia symptoms compared to placeboAnd the study did not look at other endpoints, such as levels of beta amyloid or tau proteinGreen Valley Pharmaceuticals said GV-971 may have played a regulatory role in regulating inflammation of the central nervous system by affecting the gut floraGreen Valley Pharmaceuticals plans to conduct global trials this year, pending approval from other regulatorsIf the study goes well, it is hoped that trial data will be available in a timely manner for market approval by 2025