Oligomannate pill for Alzheimer’s in China

January 6, 2020 0 By FM

China’s National Medical Products Administration (NMPA) has approved Oligomannate (GV-971) as a new drug for the treatment of mild to moderate Alzheimer’s disease (AD) and improving cognitive function, Shanghai Green Valley Pharmaceuticals announced.

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.

A phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group 36-week 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. 

Trial results demonstrated that Oligomannate statistically improves 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.