• Nicola Vanacore, Alessandro Blasimme, and Marco Canevelli.
• Centro Nazionale di Epidemiologia, Sorveglianza e Promozione della Salute, Istituto Superiore di Sanità, Roma.
• Recenti Prog Med. 2021 Jul 1; 112 (7): 495-498.

AbstractOn June 7, 2021, the US Food and Drug Administration (FDA) approved aducanumab, a monoclonal amyloid targeting β-amyloid, for the treatment for Alzheimer's disease (AD). This decision was achieved through the Accelerated Approval Pathway and was essentially motivated by the evidence that aducanumab reduces brain amyloid plaques. This news is causing a heated debate in the scientific community. On the one hand, aducanumab is the first drug to be approved for the treatment of the disease since 2003 and is the first drug to act on the alleged pathophysiological mechanisms of AD. At the same time, the evidence of clinical benefit coming from two phase 3 clinical trials is contradictory and still inconclusive. The aim of the present editorial is to provide some points to consider that can help understand the peculiarities and implications of this approval and feed the scientific debate underway.

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