China green lights first novel Alzheimer’s therapy since 2003

pharmafile | November 4, 2019 | News story | Sales and Marketing Alzheimer's, China, Green Valley, Oligomannate, pharma 

Shanghai Green Valley Pharmaceuticals has announced that its therapy Oligomannate (GV-971) has secured marketing approval from China’s National Medical Products Administration (NMPA) for the treatment of mild to moderate Alzheimer’s disease (AD) and improving cognitive function.

The decision was made under fast-track review, which was awarded back in November 2018, and marks the first approval since 2003 of a novel treatment option for Alzheimer’s disease. It is expected that Oligomannate will be made available to Chinese patients by the end of 2019.

Data supporting the decision was drawn from an 818-participant, 36-week study showing that Oligomannate was able to improve cognitive function in patients with mild to moderate Alzheimer’s in as few as four weeks, with this benefit maintained throughout each follow-up assessment.

According to the ADAS-Cog12 Score, Oligomannate outperformed placebo by a mean score of 2.54, with efficacy sustained for the full first nine months.

“The preclinical observation that Oligomannate suppresses gut dysbiosis and harnesses neuroinflammation has resulted in improvement of cognitive impairment, as evidenced by the trial results,” remarked Dr Philip Scheltens, Professor of Neurologist and CEO of Alzheimer Center Amsterdam and a Scientific Advisor to Green Valley. “These results advance our understanding of the mechanisms that play a role in Alzheimer’s disease and implies that the gut microbiome is a valid target for development of AD therapies.”

Lv Songtao, Chairman at Green Valley, also commented:  “We are very excited that Oligomannate is the first new drug approved for treating Alzheimer’s patients in the past 17 years, we are grateful to our patients and families who are the real heroes in the fight against this debilitating disease. At Green Valley, we are committed to the mission of ‘developing medicines that fulfil the biggest unmet medical needs for human health’ and have finally succeeded after 22 years of unremitting efforts. We look forward to continuing this journey to bring new treatment to all patients around the world.”

The company confirmed that it plans to launch a multi-centre Phase 3 trial across the US, Europe and Asia in early 2020 in anticipation of regulatory filings across the globe.

Matt Fellows

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