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Thursday, July 05, 2018 9:34:20 PM
Important, defining excerpts from the Biogen new release:
The study achieved statistical significance on key predefined endpoints evaluating efficacy at 18 months on slowing progression in Alzheimer’s Disease Composite Score (ADCOMS) and on reduction of amyloid accumulated in the brain as measured using amyloid-PET (positron emission tomography).
And:
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.
http://investors.biogen.com/news-releases/news-release-details/eisai-and-biogen-announce-positive-topline-results-final
Just wonderful. A monoclonal antibody that finally produces measurable, improved treatment outcomes in Alzheimer’s patients.
A threat to Anavex? A new Alzheimer’s standard of care treatment?
These are the important facts. The Biogen drug slowed the progression of Alzheimer’s symptoms. It also reduced amyloid accumulated in the brain. That’s all well and good — but not a game-changer, by any means.
Aricept, an Alzheimer’s drug already on the market likewise slows the progression of the disease. It neither reverses, prevents, or maintains start-of-treatment symptoms; merely slows their progression.
The new monoclonal antibody does, however, reduce amyloid deposits. That’s an apparent first. Nonetheless, that reduction didn’t halt the progression of the disease; merely slowed it.
The disclaimer paragraph tells the larger story. The drug is “...in development and [the release] is not intended to convey conclusions about efficacy or safety." The company admits that it may not really work very well, and may have undiscovered safety issues.
On the basis of this announcement, I won’t be buying any Biogen shares. At best, the drug (should it ever gain FDA approval) will be merely a competitor of Aricept. “Ma’am, I’m prescribing this new Biogen drug for your husband. It will slow the progression of his Alzheimer’s, but won’t prevent his eventual death from the disease. It’s the best we have.”
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