The Food and Drug Administration has approved the Alzheimer’s drug aducanumab despite controversy over whether there is sufficient evidence to support the drug’s effectiveness.
Aducanumab is the first Alzheimer’s drug approved by the FDA in almost 20 years. It has been developed by the company Biogen in collaboration with a Japanese firm Eisai. It is the first drug approved that aims at a protein called amyloid beta that builds up in the brains of Alzheimer’s patients.
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The controversy stems from the fact that there is only one positive study so far showing the drug’s effectiveness. In November, 10 members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted “no” when asked if it was reasonable to consider one positive study as the evidence for the effectiveness of aducanumab. One other member voted “uncertain.”
The drug’s target population are those in the early stages of dementia, when it could stop the progression of the disease, not just merely treat the symptoms. It will not be used for those in the advanced stages of the disease.
Public interest organizations such as the Public Citizen have opposed approval, warning that approving aducanumab “despite the lack of evidence of effectiveness” will provide “false hope to millions of Alzheimer’s disease patients and their families.”
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Other groups such as the Alzheimer’s Association have supported approval, calling it “an exciting moment for millions of Americans and their loved ones who have waited decades for a new, more effective treatment for Alzheimer’s disease to be available.”
