Biogen Alzheimer’s Drug Pulled from European Application Process

Following a rocky series of setbacks in Europe and abroad, Biogen has backed out of the application process in Europe for it’s controversial Azheimer’s disease (AD) drug Aduhelm. The European Medicines Agency (EMA) had rejected the application in late 2021 based on safety concerns. In addition,  although Aduhelm reduced amyloid protein burden, a key hallmark and major contributor to AD pathology, many questioned the drug’s effect on clinical outcomes.

According to Zachary Brennan of Endpoints News, “Meanwhile, the company’s data on how the drug affected cognition are “conflicted,” the EMA said. One of two identical studies failed; the other showed a small benefit in the high dose cohort. These studies “did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease,” EMA said.”

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(Source: Endpoints News, April 22^nd, 2022)