China approves oligomannate for mild-to-moderate Alzheimer's

In what could prove to be something of a landmark development, Shanghai-based Green Valley Pharmaceuticals says that China's National Medical Products Administration (NMPA) has granted conditional approval for oligomannate (GV-971) as new drug for the treatment of mild-to-moderate Alzheimer's disease (AD) and improving cognitive function."

The 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, a drug derived from marine algae, 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 company said.

Green Valley will launch oligomannate very soon in China, and plans to submit the marketing authorization applications in selected countries following its launch in China. A multicenter global Phase III clinical trial (GREEN MEMORY) with sites in the US, Europe and Asia is planned to be initiated in early 2020 to support global regulatory filing of oligomannate. The approval comes with the condition that further research is carried out to show long-term safety and efficacy.