The FDA approved a drug for the treatment of Alzheimers on June 6, 2021.
Today FDA approved Aduhelm (aducanumab) to treat patients with Alzheimer’s disease using the Accelerated Approval pathway, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit.
In all of my experience with biotechnology, I have never worked at a company or research laboratory that did not have an amyloid beta project underway. Aduhelm is an antibody that binds to amyloid beta. In my core belief in the cynefin method of thinking (simple, complicated, complex), this approach has always been simple. Alzheimers, the human brain and aging are complex. Amyloid beta as a drug target is simple using complicated research and complicated methods of developing an antibody. Clinical trials are also complicated. BUT... to merely hire scientists to develop an antibody against Amyloid Beta is simple. Telling doctors and clinical trial specialists to hammer that square peg through a round hole is simple.
But it didn't work. At least that was the conclusion in:
https://www.health.harvard.edu/blog/a-new-alzheimers-drug-has-been-approved-but-should-you-take-it-202106082483
Once again, we really should look into science that isn't science. What prompted the powers that be to approve the drug? The need to fill the gap was too great. They needed to offer something even though that something doesn't work.
What happens next? The answer is well known in the pharmaceutical industry. If the patient gets better... claim responsibility. If they get worse... they came too late. If they stay the same... up the dose.
