On June 7th 2021, the Food and Drug Administration (FDA) granted approval for 
Aduhelm (aducanumab) for the treatment of Alzheimer's disease under its 
accelerated approval program. Aducanumab is the first putative disease-modifying 
therapy (DMT) approved for the treatment of AD with a great potential for 
clinical benefit over current symptomatic therapies. The scientific community 
has been largely confounded by this historical decision since this has been 
based on the reduction of a surrogate marker (amyloid beta) and not on data 
showing clinical efficacy. Here we provide a regulatory perspective on the topic 
and discuss potential similarities and differences between the FDA's and EMA's 
evaluative processes.