A New Drug for Alzheimer’s? What We Know So Far. . .
The Food and Drug Administration recently approved a new drug called aducanumab, marketed as Aduhelm and created by the drug company Biogen. It is a amyloid beta-directed antibody used to reduce the plaques that are characteristic of Alzheimer’s. Despite this seemingly positive news, there still remains many questions unanswered, as well as some controversy around the approval. In today’s blog, we will describe what potential breakthroughs this drug can have for those living with Alzheimer’s, as well as the associated controversies that came with the FDA’s approval of aducanumab. 
Why Is This a Big Deal?
The excitement around aducanumab comes from the fact that it specifically targets and reduces the plaques that build up in the brain of those living with Alzheimer’s. This was the first drug approved by the FDA for Alzheimer’s since 2003. The news comes as a big decision on behalf of the FDA. However, not everybody agrees that it was the right move.
The controversy lies in the fact that even if the drug reduces plaques that affect the brain of individuals with Alzheimer’s, there is no evidence yet that it slows down the progression of the disorder. An outside panel of expert advisers reviewing the current research objected to the FDA’s approval of the drug.
Sources of Contention
The FDA is urging Biogen to conduct another clinical study to demonstrate that plaque reducing effects of aducanumab produces a clinical improvement to patients.  The FDA, however, is already suggesting that it does indeed provide a clinical benefit to patients, but outside experts do not agree because of a lack of evidence and contradictory data.
To add to the controversy, potentially serious side effects of aducanumab exist. Reported, although rare, side effects include swelling and bleeding in the brain. This fact led some medical professionals to be wary of prescribing the new medicine despite FDA approval.
What is the Cost of Treatment?
Biogen’s established price of treatment of aducanumab is a weekly infusion that costs $4,312 per infusion for an average weight person with mild dementia. The annual cost would be around $56,000. Out-of-pocket costs for patients will vary depending on their insurance plans.
Dr. Jason Karlawish, a professor of medicine, medial ethics, and health policy at UPenn, believes that putting aducanumab on the market will stress Medicare’s resource and that it is not worth the cost. His reasons are that there is insufficient evidence to believe the drug is effective and safe. He also states that the current news around aducanumab does not have to be bad. Instead, Biogen should invest time and resources in completing drug trials to determine whether the drug provides a significant benefit to patients or not.
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