China has approved the first home-grown drug for the treatment of "mild to moderate Alzheimer''s disease (AD) and improving cognitive function", according to its developers.
The new drug, Oligomannate (GV-971), is the first to be approved for Alzheimer''s disease globally since 2003, said Green Valley Pharmaceutical Co., which developed the drug along with Ocean University of China, Shanghai Institute of Materia Medica under Chinese Academy of Sciences.
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, Green Valley Pharmaceutical said. A multi-centre global phase 3 clinical trial with sites in the US, Europe and Asia is planned to be initiated in early 2020 to support global regulatory filing of Oligomannate.
An effective treatment for Alzheimer''s that affects about 48 million people in the world could easily become a big hit globally. China''s National Medical Products Administration granted Oligomannate fast-track review in November 2018.
Over 800 patients with the diagnosis of mild to moderate Alzhemer''s disease completed the Phase 3 clinical trial conducted in 34 tier-1 hospitals across China. Results of the 36-week-long study showed that Oligomannate can improve cognitive function in mild-to-moderate Alzheimer''s disease patients as early as week 4 and the benefit was sustained at each follow-up assessment visit.
Alzheimer''s disease is a progressive brain disorder that impairs memory, affecting the ability of patients to carry out simple tasks.