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Aducanumab: Biogen Is The Latest Firm To Preempt A Negative EU Opinion On Approval

 
• By Ian Schofield

The EU marketing application for aducanumab is heading for a rejection for Alzheimer’s disease, according to a “negative trend vote” at the CHMP disclosed by the drug’s sponsors.

Pills with euro union flag, medicine
The CHMP can OK or reject EU drug approval applications • Source: Shutterstock

In disclosing last week’s “negative trend vote” by the European Medicines Agency’s human drugs committee (CHMP) on EU approval of their Alzheimer’s drug aducanumab, Biogen, Inc. and Eisai Co., Ltd. join the lengthening list of companies that have gone against the EMA’s advice not to divulge such information.

The vote, which signals that the CHMP is unlikely to recommend marketing authorization for aducanumab at its next monthly meeting...

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