<unk> , sold under the brand name Aduhelm, is a medication designed to treat Alzheimer's disease (AD). It is an amyloid beta-directed monoclonal antibody that targets aggregated forms of amyloid beta (Aβ) found in the brains of people with Alzheimer's disease to reduce its buildup. It was developed by Biogen and Eisai.<unk>  was approved for medical use in the United States by the Food and Drug Administration (FDA) in June 2021, 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. 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.<unk> 's approval is controversial due to ambiguous clinical trial results surrounding its efficacy. In November 2020, a panel of outside experts for the FDA concluded that a pivotal study of<unk>  failed to show "strong evidence" that the drug worked, citing questionable efficacy and multiple "red flags" found with the data analysis. Nevertheless, the drug was approved under the FDA's accelerated approval pathway, and the FDA requires Biogen to perform a follow-up study to see if the drug helps treat symptoms of Alzheimer's. The Office of Inspector General, U.S. Department of Health and Human Services has been asked to investigate interaction between the drug company and the FDA prior to the drug's approval.<unk>  has since been approved by the Ministry of Health and Prevention in the United Arab Emirates as of 3 October 2021, making it the second country in the world to approve the treatment.
Aducanumab
Evolocumab
Alirocumab
Emapalumab
Tralokinumab
Olaratumab
Ustekinumab
Anifrolumab