By: Jeet Parikh
Over 11% of people over 65 are diagnosed with Alzheimer’s dementia -- that is one in every nine people! Additionally, one in three seniors dies with Alzheimer’s -- more than breast cancer and prostate cancer combined. So what exactly is Alzheimer’s Disease? Alzheimer’s disease is a progressive neurological disease that destroys memory and other mental functions. It is the most common cause of dementia, marked by memory loss and cognitive decline. Unfortunately, no cures yet exist for this chronic disease.
Enter the FDA's recent approval of Biogen's drug Aducanumab (Aduhelm) … understandably seen by the public as a big deal. Amyloid-beta plaque buildup, which can lead to neuronal death, is hypothesized to be a key sign of Alzheimer's disease. Aduhelm targets these plaques by attaching to them and recruiting your immune system to get rid of them with the intent of reducing the cognitive decline of Alzheimer’s.
Despite the approval of this innovative solution, significant controversy arose from the FDA’s approval, and it stemmed from the studies conducted to test the drug. Biogen conducted two large-scale studies that looked into the efficacy of Aduhelm. While the drug did lower the number of beta-amyloid plaques, its effects of stopping cognitive decline were inconsistent. One study showed some weak evidence regarding the benefit of the drug, and the other study showed no significant improvement between test groups.
Despite these concerning results, the FDA approved the drug using a different criterion called accelerated approval. This criterion is used for drugs that treat serious diseases and only require efficacy for an intermediate endpoint. In this case, the intermediate endpoint was the beta-amyloid plaques, and because the studies did show a successful reduction in these plaques, the drug was approved.
Of the ten members on the advisory group of drug approval for the FDA, three resigned. Despite the group ruling 10-1 against the drug’s approval, the FDA approved the drug anyway. The lack of substantial evidence regarding its efficacy has been concerning for hospitals. Two major health systems, the Cleveland Clinic and Mount Sinai’s Health System, have chosen not to administer the drug until further testing has been done.
Overall, while Aduhelm is exciting and has great potential in treating Alzheimer’s (and potentially other neurodegenerative diseases), substantial work still needs to be done to prove its efficacy.
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What Did You Learn?
Questions:
What is Aduhelm, and how does it work?
Aduhelm is a drug developed by Biogen that the FDA approved for use in Alzheimer’s patients. Aduhelm targets amyloid-beta plaques in the brain that can lead to neuronal death. This amyloid-beta plaque buildup has been hypothesized to be a key sign of Alzheimer’s disease. The drug attaches to the plaques and signals your immune system to get rid of them with the intent of reducing the cognitive decline of Alzheimer’s.
What was the controversy surrounding Aduhelm’s approval?
Biogen conducted two studies to test the efficacy of Aduhelm. One study had weak evidence for slowing cognitive decline, while the other showed no evidence. In addition, the FDA’s advisory group voted 10-1 against approving the drug. Despite this, the FDA approved the drug anyway, and in response, some major health systems such as the Cleveland Clinic and the Mount Sinai’s Health System have refused to administer the drug. More research is needed until the drug’s efficacy can be proven.