Tuesday, October 22, 2019

Aducanumab: Back from the Dead

Back in March, we joined the rest of the world in declaring that Aducanumab was dead as a treatment for Alzheimer's disease.  An independent futility review found that the phase 3 (final) trial was not sufficiently promising to justify its continuation, so it was halted.  I had auditioned for the trial in 2016, but was glad not to have been accepted.  And that was that ... or so it seemed. 

But just today the word got out that Biogen and their partner, Eisai of Japan, weren't done with Aducanumab after all.  They said they will apply to the FDA for a license for the drug next year!  It's hard to tell what happened, because, so far, the big news is that Biogen's stock shot up 28%, not that there was new hope for curing Alzheimer's disease.  But it does seem that a more extensive review of the data sets justified declaring the trial a success and applying for a license.

Something that surprised me a few months ago was some grumbling I heard about Biogen being stingy about sharing the trial data.  Apparently it's customary to make data from abandoned drug trials available to other researchers, but it seems Biogen wasn't doing that very openly.  Sounds like they were still crunching the numbers.

Not everyone is sure that this is for real.  One publication outlined the doubts.  

This event was brought to my attention today by Dr. Moon (who wrote the foreword to Beating the Dementia Monster) and a neurologist who will be reviewing the new edition.

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