• Kat J. McAlpine

    Editor, The Brink Twitter Profile

    Kat J McAlpine

    Kat J. McAlpine is editor of The Brink, Boston University’s news site for scientific breakthroughs and pioneering research. Kat has been telling science stories for over a decade, and prior to joining BU’s editorial staff, publicized research at Boston Children’s Hospital, Harvard University’s Wyss Institute for Biologically Inspired Engineering, and the University of Connecticut’s School of Engineering. Profile

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There are 2 comments on Biogen’s New Alzheimer’s Drug Is “Hugely Important,” “One of the Biggest Moments” in 20 Years

  1. I was very surprised by this article after hearing that the review panel was set to strongly recommend against approving this drug. The interview I heard said the effects in the positive study were minuscule and that the other study was firmly negative. And here is an article in science news: https://www.sciencemag.org/news/2020/11/biogen-s-alzheimer-s-drug-candidate-takes-beating-fda-advisers
    What is the truth and is trump’s FDA pushing for approval against better evidence?
    Also see link within science news article to a perspective article by the review panel published in Alzheimer and Dementia.

    1. The improvements in the positive study suggest patients could get 2-3 more years of getting dressed by themselves, driving, managing finances, and playing with grandkids. For older AD patients, this could very much be worth it. Pos study results were significant in a number of improvement categories for the high dose, with apparent efficacy fading perfectly in line with decreasing dose levels down to placebo.
      Negative trial results were bad, but Biogen explanation actually makes some sense. Pos trial started weeks after neg trial. Weeks in, Biogen amended the protocol and raised the high dose. Therefore, those in the pos trial received more high doses than patients in the neg trial, because neg trial patients already had been given their first several doses before protocol amendment raised the dose.

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