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Aduhelm Looks Set For Rejection In Europe For Alzheimer's

Adds To US Woes

 
• By Andrew McConaghie

The EMA’s likely rejection is no surprise for Biogen and Eisai, but adds to problems in the same week as Biogen’s R&D leader announced his departure.

Biogen_Switzerland
Hopes of an EU launch in 2022 are now diminishing, with EU regulators expected to demand a further trial to demonstrate Aduhelm' s efficacy. • Source: Alamy

The European Medicines Agency’s expert committee looks set to reject Biogen and Eisai’s Alzheimer’s treatment Aduhelm (aducanumab), adding further bad news to the drug’s troubled and controversial US launch.

The companies announced on 17 November that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a "negative trend vote" following an oral explanation on the

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