Doubts Over China's First Alzheimer's Drug Resurface Amid Research Miscount Allegation

Speed Over Quality?

Biogen/Eisai’s US filing of aducanumab for Alzheimer’s has a ripple effect in China, where a leading biomedical researcher has publicly questioned data for the country’s first approved drug for the disease, GV971.

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LEADING RESEARCHER QUESTIONS CHINA AD DRUG GV971 - 'IMPOSSIBLE WITHOUT FABRICATION' • Source: Shutterstock

Alleging that the research behind GV-971, China’s first approved drug to treat Alzheimer’s disease (AD), is “impossible if there is no fabrication”, a leading researcher in China has raised doubts over the product via an open letter, just at the time when Biogen, Inc. has made a much-anticipated US filing for its candidate aducanumab.

The US firm, along with partner Eisai Co., Ltd., has just submitted a biologics license application for aducanumab, an amyloid-beta-clearing antibody, despite predictions from some analysts of a complete response letter requiring a third Phase III trial

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