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New Alzheimer’s drug sparks controversy

A new compound designed to fight Alzheimer’s disease, which affects 30 million people worldwide, is causing controversy. On June 7, the US Food and Drug Administration (FDA) authorized the use of the monoclonal antibody aducanumab to combat the possible cause of the disease. Produced by American biotechnology company Biogen, Aduhelm is the first Alzheimer’s drug approved since 2003 (New York Times, June 7). Unlike other compounds in use, which only delay the onset of symptoms, the new drug acts on the possible biological origin of the disease. The compound was authorized for sale through the FDA’s accelerated approval program, which aims to improve access to drugs for diseases that have yet to be effectively treated, despite an independent advisory committee’s assessment that there was no evidence that the drug provides any benefit. One clinical trial found that the medication slightly delays mental decline, while another showed no better results than the placebo—both were stopped early because the drug appeared not produce any significant benefit. In July, as the result of criticism from experts, the FDA restricted the drug’s indication to mild cases only. On July 9, an independent federal agency was asked to investigate the authorization of Aduhelm. It is suspected that Biogen representatives and FDA officials interacted informally prior to the approval (Stat, July 9; New York Times, July 9).