New drug for the treatment of Alzheimer’s disease

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FDA approves new drug for the treatment of Alzheimer’s disease. 

The FDA has approved a new drug for the treatment of Alzheimer’s disease. The drug, called aducanumab, is the first drug to be approved for the treatment of Alzheimer’s in nearly 20 years.
Aducanumab is a monoclonal antibody that targets amyloid plaques, which are thought to play a role in the development of Alzheimer’s disease. The drug was approved based on the results of two clinical trials that showed that it slowed the progression of Alzheimer’s disease.
The approval of aducanumab is a major breakthrough for the treatment of Alzheimer’s disease. However, it is important to note that the drug does not cure Alzheimer’s disease and it is not a miracle cure. The drug can help to slow the progression of the disease, but it will not reverse the damage that has already been done.

Aducanumab was approved for medical use in the United States by the Food and Drug Administration (FDA) in June 2021,[8] in a controversial decision that led to the resignation of three advisers to the FDA in the absence of evidence that the drug is effective.[9][10][11] The FDA stated that it represents a first-of-its-kind treatment approved for Alzheimer’s disease and that it is the first new treatment approved for Alzheimer’s since 2003.[1] Aducanumab’s approval is controversial for numerous reasons including ambiguous clinical trial results regarding efficacy, the high cost of the drug and the very high rate of serious adverse events.[12][11] The FDA considers it to be a first-in-class medication.[13]

In November 2020, a panel of outside experts for the FDA concluded that a pivotal study of aducanumab failed to show strong evidence that the drug worked, citing questionable efficacy and multiple red flags found with the data analysis.[14] There were also significant health risks associated with the drug; brain swelling or brain bleeding was found in 41% of patients enrolled in the studies.[15] Nevertheless, the drug was approved under the FDA’s accelerated approval pathway, and the FDA requires Biogen to perform follow-up reviews to assure the drug is a safe and effective treatment for Alzheimer’s disease.[1][16] The Office of Inspector General, U.S. Department of Health and Human Services was asked to investigate interaction between the drug company and the FDA prior to the drug’s approval.[17]

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