Aducanumab: Appropriate Use Recommendations

Abstract

June 7, 2021 will not likely be forgotten soon by many Alzheimer Disease (AD) researchers. To paraphrase a famous quote: ”a small step for man, but a giant leap forwards for the field”. That day, AduhelmTM (aducanumab) was approved by the US Food and Drug administration (FDA), because of its profound effect on amyloid plaques as shown by amyloid PET as a surrogate marker. Although this decision was not met with great enthusiasm uniformly, the general feeling during a 4 hour webinar hosted by the Alzheimer Association (1) was that the benefits seem to outweigh the risks, but proper guidance was needed on who would be eligible for treatment, because all attendees felt the label was far too broad and unspecific. The latter was amended on july 8, jointly by FDA and Biogen to more accurately reflect the eligible patient population that was studied in the Phase III program.