23 September 2021 - The accelerated approval by the US FDA of Biogen’s monoclonal antibody aducanumab (Aduhelm) for treatment of patients with Alzheimer disease has created a controversy. 

Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, which nearly unanimously rejected approval of aducanumab, resigned over the decision. Some major academic medical centres declared that they will not prescribe the Biogen drug. 

An inspector general is investigating reports of irregular contacts between FDA officials and Biogen executives. In addition, many were outraged by Biogen’s price of $56 000/year for aducanumab. Conversely, patient groups, such as the Alzheimer Association, endorsed the first FDA approved drug for Alzheimer disease in 18 years. 

This controversy forces the question of how to improve accelerated approval.

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