On August 7, Biogen announced that they had received notice from the FDA that they had accepted Biogen's application for approval of aducanumab, and that it will be fast-tracked. This means the review process will be cut from 10 months down to six.
We are all anxious to see this move along. We discussed previously how we got here and what the prospects are for an approved, effective pharmacological treatment for Alzheimer's disease. We just don't know what the FDA will make of the application.
On the one hand, we are so desperate for a medication that will actually slow the progress of the disease that the FDA will be encouraged to approve it, warts and all. On the other hand, its effectiveness remains in question, and it's known to sometimes cause micro-hemorrhaging in the brain. In the best of outcomes, it only slows progress of the disease, it does not reverse or even stop it.
So let's say that the FDA approves it. Biogen has put a LOT of money into research and development, and they will want return on their investment. So how much will it cost? And then, this will not be a pill. You will need infusions by needle once or twice (I believe) per month. I'm not sure how long that would go on for, but likely for the rest of your life. And with the micro-hemorrhaging, the patient will need frequent MRIs to watch for the development of problems.
The buzz in the medical field is that the lifestyle changes we discuss in Beating the Dementia Monster will remain our best bet for treatment of the disease for quite a while to come.
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