What is the controversy over Aducanumab/Aduhelm for Alzheimer's?

In June 2021, the FDA approved Aducanumab/Aduhelm as the first new drug for Alzheimer’s disease in 18 years. It sparked controversies, surprises and even disappointment among scientific communities. Upon approval, three FDA advisers resigned due to the lack of evidence that the drug is effective. One month later, FDA Acting Commissioner Dr. Janet Woodcock requested an investigation to look into the interactions between the FDA and the company Biogen. The review process for the drug "took several unusual turns, including a decision for the FDA to work far more closely with Biogen than is typical in a regulatory review."

Aducanumab was discovered as early as 2007 by the Swiss biopharmaceutical company Neurimmune and multinational biotech company Biogen. Developing an immuno-therapy for Alzheimer’s, like aducanumab, started in the late 1990s. Its mechanism of action is based on the amyloid hypothesis. A landmark report by Dale Schenk and the coworkers suggests the cause of Alzheimer’s disease is a decade-long build-up of a protein in the brain, known as beta-amyloid. The build-up of amyloid can damage the brain’s nerve cells, leading to memory loss, learning deficiency, deficits in space orientation and speech. Schenk and coworkers suggested the possibility of active immunization to prevent or ameliorate the build up of amyloid and therefore Alzheimer’s diseases. The immunotherapy Aducanumab is a fully human lgG1 monoclonal antibody that targets aggregated amyloid and removes it from the brain. Although approved, Aducanumab is estimated to cost patients 50000 dollars a year for the treatment.

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Видео What is the controversy over Aducanumab/Aduhelm for Alzheimer's? канала Daniel S.