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Biogen Alzheimer’s Drug Fails to Gain FDA Panel’s Backing

  • Outside advisers’ vote follows upbeat assessment by agency
  • Panel says data from trial is insufficient to support approval
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Biogen Inc.’s experimental Alzheimer’s disease therapy failed to gain support from a panel of U.S. Food and Drug Administration advisers on Friday, putting the drug at a crossroads as the agency weighs approval.

The outside experts voted 8 to 1, with 2 undecided, that data from a single clinical trial with positive results was insufficient to show Biogen’s drug works. They also voted 10 to 0, with 1 undecided, that the positive study shouldn’t be considered primary proof the drug works in light of conflicting evidence from a different trial.