EMA Panel Gives Biogen’s Aduhelm a Thumbs Down

Biogen’s Aduhelm (aducanumab) appears unlikely to receive a marketing authorization in the EU, after a European Medicines Agency expert panel issued a “negative trend” vote on the antiamyloid antibody.

The EMA, which generally follows the recommendations of the expert panel — the Committee for Medicinal Products for Human Use — will issue a final decision in mid-December.

Biogen said it will continue to lobby for the drug’s approval.

“We strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease,” said Priya Singhal, Biogen’s head of global safety and regulatory sciences.