Authorization

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 /CNW/ --AShanghai Green Valley Pharmaceuticals (Green Valley) today announced that China'sANational Medical Products AdministrationA(NMPA)Ahas approved Oligomannate (GV-971) asAnew 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. AIt is the first novel drug approved for Alzheimer's disease globally since 2003. AOligomannate will provide a new treatment option to fight Alzheimer's diseaseAfor patients and is expected to be available in China by the end of 2019.Study ResultsThe 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 diseaseAcompleted the study. The trial was conducted in collaboration with IQVIA (formally Quintiles) and Signant Health (formerly Bracket) among other partners.Trial results demonstrated that OligomannateAstatistically 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 OligomannateAand placebo groups in ADAS-Cog12 Score (a standard cognitive measure commonly used in AD studies) was 2.54 (p< 0.0001), withAsustained 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.
See also:
Leave a comment
News
  • Latest
  • Read
  • Commented
Calendar Content
«     2019    »
 123
45678910
11121314151617
18192021222324
252627282930