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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.

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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

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