GRAND RAPIDS, Mich. — The Food and Drug Administration has approved a new drug to treat Alzheimer's Disease. While questions remain over the experimental treatment’s effectiveness in slowing disease progression, researchers are calling it "remarkable."
Aduncanumab is the first drug the FDA has approved for Alzheimers treatment in nearly 20 years, drugmaker Biogen says it will help slow the progression of the memory destroying disease, which afflicts 6 million Americans.
There were two major studies of the drug conducted, one found no benefit to taking the drug, the second showed a 22% reduction in cognitive decline.
In November the FDA's Peripheral and Central Nervous System Drugs Advisory Committee was asked if it was reasonable to consider the data from one positive study for the drug's effectiveness. Ten of the panel members voted "no," and one was "uncertain.”
“I think this is really encouraging for the field, that this really complex and devastating disease, may actually be able to modify it to slow progression to stop progression,” says Michael Henderson, PhD.
Henderson is a professor and neuroscientist at Van Andel Institute in Grand Rapids.
He’s says while there are questions if the drug will indeed slow the progression of Alzhemier’s, there’s no question that the drug can do what its aimed to do; Destroy a toxic protein that clumps in the brains of Alzheimer’s patients.
“They're providing the antibody so your body can recognize that protein and hopefully clear from the brain. And I think what these types of studies have shown is that we had thought maybe this wouldn't be efficacious in the brain, but it turns out that that they can enter the brain and remove some of these toxic proteins,” Henderson explained.
“I think it's really remarkable that all the research done has really shown that this is a possible way to clear what we think is a toxic protein from the body,” he added.
That fact could be a breakthrough for not just Alzheimer’s but research into other neurodegenerative diseases.
“Hopefully this is kind of a proof of principle molecule that we could use similar techniques to target other you know proteins that may have even a larger impact,” says Henderson.
It will take several months for the drug to become available and when it is, it will be expensive. Estimates are ball-parked at $30-50,000 for the first year of treatment.
The manufacturer will also be required to do another clinic trial while its available for public use.