Biogen's Alzheimer's drug Aduhelm faces EU rejection

Biogen hasn't won support to have its Alzheimer's treatment Aduhelm marketed in the EU, as the drug has received a negative opinion in a trend vote from the EMA's expert committee, the CHMP. The formal rejection of Biogen's marketing authorization application is expected in December.

Photo: POOL New/VIA REUTERS / X80003

The controversial approval of Biogen's drug Aduhelm (aducanumab) in the US hasn't been followed by a corresponding approval in the EU, the company itself reports in a press release on Wednesday.

An oral presentation held by Biogen in November was followed by a so-called trend vote from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). It resulted in members of the committee adopting a negative opinion on the drug and thus no backing for a potential marketing approval in the EU. A formal rejection is expected to be announced at the CHMP's monthly meeting in December.

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