FDA panel weighs approval of Alzheimers drug that claims to slow mental decline
WASHINGTON - According to the Alzheimer's Association, more than 5 million Americans suffer from Alzheimer's Disease and as of November 2020, one drug company claims it has created a medicine that will help many of these patients.
The Associated Press reports that a panel with the Food and Drug Administration (FDA) is analyzing the drug, which was produced by a partnership between a Massachusetts-based company called Biogen Inc. and a Japanese company called Eisai Co.
While the FDA panel is considering whether or not to approve the drug for use in the US, it should also be noted that the FDA is not required to follow this panel's advice. That said, the organization typically adheres to the panel's expert opinion.
The FDA has until March to make a decision on the new drug.
The medication in question is called Aducanumab (pronounced “add-yoo-CAN-yoo-mab”) and does not cure or reverse Alzheimer’s, Biogen Inc. and Eisai Co says. Instead, the companies claim Aducanumab modestly slows the rate of decline.
However, evidence of the drug's success is scarce. The Associated Press says Biogen and Eisai halted two studies in 2019 when the drug didn’t seem to work, then did an about-face and said additional results suggest it was effective in one study at a high dose. Those results have yet to be published.
On the other hand, an FDA staff report released Wednesday gave a generally positive view, saying the positive study might be “exceptionally persuasive.” However, an FDA statistician noted flaws and inconsistencies in the results and potential safety issues.
Aducanumab is said to work by being administered once a month through an IV. During this process, it reportedly clears harmful clumps of a protein called beta-amyloid from the brain. Other experimental drugs have also done this. But the action hasn't appeared to make any difference in patient's ability to think, care for themselves or live independently.
According to the Associated Press, the new drug is a biotech medicine made from living cells, and as such, comes with a high price tag.
Though no specific cost has been announced for the drug, Biogen drugs for other diseases cost $3,500 a month, plus fees for each infusion.
If aducanumab is approved, it’s expected to be covered by Medicare, the government plan for seniors, the Associated Press reports; the FDA and Medicare are barred from considering cost when reviewing a new drug or treatment.
Many health care experts are cautious when it comes to drugs such as aducanumab.
In an Associated Press article, Dr. Eliezer Masliah of the U.S. National Institute on Aging said that any benefit from the drug “is relatively small.”
In the positive study, the drug slightly slowed the rate of mental decline -- a difference of only 0.39 on an 18-point score of thinking skills. What that means in terms of being able to live independently, recognize family members or remember things currently remains unclear.
'Drugs that remove amyloid may have to be combined with medicines that do other things in the brain, and used early enough before damage occurs, to do much good,' Masliah said.
The American Academy of Neurology has asked the FDA that should it approve the drug, the FDA consider not making it a broad authorization, as this could expose many patients to a medicine that might harm rather than help, and could “overwhelm the health care system.”
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