European Regulator Votes Down Biogen's Alzheimer's Drug

European Regulator Votes Down Biogen's Alzheimer's Drug
  • Following an oral explanation held at the November meeting of the EMA's human medicines committee, Biogen Inc BIIB received "a negative trend vote" on its marketing application for its controversial Alzheimer's drug aducanumab.
  • "While we are disappointed with the trend vote, 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, head of global safety & regulatory sciences and interim head of R&D at Biogen.
  • The CHMP is expected to adopt a formal opinion on the Marketing Authorization Application at its December meeting, Biogen said.
  • Recently, Biogen announced new Phase 3 findings that provide further evidence of aducanumab's effect on lowering amyloid-beta plaque and downstream tau pathology.
  • Price Action: BIIB shares are down 1.74% at $257 during the market session on the last check Wednesday.
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