China Approves Seaweed Sugar as First New Alzheimer’s Drug in 17 Years
Just as the clamor about Biogen’s seeking FDA approval for aducanumab with one positive Phase 3 trial started to die down, a Chinese company garnered a regulatory thumbs-up for its drug, also with one Phase 3 trial. On November 2, Shanghai Green Valley Pharmaceuticals announced [1]that China’s National Medical Product Administration (NMPA) had conditionally approved GV-971, aka oligomannate, for the treatment of mild to moderate Alzheimer’s disease. Full approval, expected to come in spring 2020, hinges on the company submitting animal safety studies that have already been completed, according to a spokesperson for the company.
GV-971 conditionally approved in China to treat AD.
Drug met its one primary, but not secondary endpoints, in a single Phase 3 trial.
Global Phase 3 trial slated to begin in 2020, in United States, Europe, China.
A single Phase 3 [2] study apparently found that GV-971, reported to alter the gut microbiome, slowed cognitive decline in people with AD. The trajectory of cognitive change in the nine-month trial raised some eyebrows—for one, the placebo group did unusually well for weeks before their cognitive scores plummeted. A global Phase 3 trial, slated to begin in 2020, will test if GV-971 passes muster in the United States, Europe, and China.
Read the full article here on the Alz Forum: https://www.alzforum.org/news/research-news/china-approves-seaweed-sugar-first-new-alzheimers-drug-17-years [3]