The Food and Drug Administration (FDA), the US government agency for food and drug safety, has authorized the use of the drug Aducanumab, developed to slow the progression of Alzheimer’s disease, the most common form of degenerative dementia. It is the first Alzheimer’s drug licensed in the United States in the past 18 years; moreover, unlike all the drugs authorized so far, it is the first to intervene on the causes of the disease rather than on the symptoms. The drug was developed by the US pharmaceutical company Biogen and will be sold in the US under the name Aduhelm.
However, the FDA’s decision is particularly controversial: in 2019 Biogen suspended the trial on Aducanumab because it had not led to significant progress, only to review the data and restart clinical trials. In addition, last November, ten of the eleven members of the FDA’s board of scientific experts spoke out against its authorization, arguing that there was not enough evidence of its effectiveness.
However, the FDA has asked Biogen to initiate very large new clinical trials, which could take years to complete. In the meantime, however, the drug can be marketed.
The director of the FDA’s Center for Drug Evaluation and Research, Patrizia Cavazzoni, said she was aware of the conflicting opinions, but explained that there are “reasonable chances” that the benefits of Aducanumab outweigh the possible risks to patients. Cavazzoni added that the agency “expects” the drug to actually slow the decline of cognitive abilities in patients suffering from Alzheimer’s.
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