Green Valley Announces NMPA Approval Of Oligomannate For Mild To Moderate Alzheimer's Disease
-- Oligomannate , A New Oral Treatment For Mild To Moderate Alzheimer's Disease
-- The Only Approved Novel AD Treatment Globally Since 2003
SHANGHAI, Nov. 2, 2019 /PRNewswire/ -- Shanghai Green Valley Pharmaceuticals (Green Valley) today announced that China's National Medical Products Administration (NMPA) has approved Oligomannate (GV-971) as new drug for the treatment of "mild to moderate Alzheimer's disease (AD) and improving cognitive function."
NMPA granted Oligomannate for fast-track review in November 2018. It is the first novel drug approved for Alzheimer's disease globally since 2003. Oligomannate will provide a new treatment option to fight Alzheimer's disease for patients and is expected to be available in China by the end of 2019.
The Phase 3 clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group 36 week study led by Peking Union Hospital and Shanghai Jiaotong University Medical School Mental Health Center. The study was conducted in 34 Tier-1 hospitals across China. A total of 818 patients with the diagnosis of mild to moderate Alzhemer's disease completed the study. The trial was conducted in collaboration with IQVIA (formally Quintiles) and Signant Health (formerly Bracket) among other partners.
Trial results demonstrated that Oligomannate statistically improve cognitive function in mild-to-moderate AD patients as early as week 4 and the benefit was sustained at each follow-up assessment visit. The mean difference between Oligomannate and placebo groups in ADAS-Cog12 Score (a standard cognitive measure commonly used in AD studies) was 2.54 (p< 0.0001), with sustained efficacy from first month of treatment to the end of 9 months of treatment. Oligomannate was safe and well tolerated with side effects comparable to the placebo arm.
"I have been doing research on Alzheimer's disease for 50 years, participated in multiple global multi-center studies of multiple drugs, and have never found a satisfactory treatment for Alzheimer's disease," said Professor Zhang Zhenxin, MD, a leading principal investigator of the phase 3 trial of Oligomannate and professor of Neurology at Peking Union Medical College Hospital in Beijing. "The result of the 9-month trial of Oligomannate is exciting. We finally see hope and dawn. I am sincerely happy for the patients and their families."