TY - JOUR T1 - Aducanumab for Alzheimer’s disease – too many unanswered questions JF - Drug and Therapeutics Bulletin JO - Drug Ther Bull SP - 130 LP - 130 DO - 10.1136/dtb.2021.000043 VL - 59 IS - 9 AU - David Phizackerley Y1 - 2021/09/01 UR - http://dtb.bmj.com/content/59/9/130.abstract N2 - In June 2021, the US Food and Drug Administration (FDA) announced that it had approved aducanumab for the treatment of Alzheimer’s disease.1 The FDA used its accelerated approval process, which allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a marker of the disease rather than a patient-oriented outcome. In this case, the approval decision was based on levels of amyloid-beta in the brain, an unvalidated surrogate marker. A recent review has called into question evidence linking this surrogate marker to an effect on cognitive function.2 Furthermore, in November 2020, the specialist committee that advised the FDA on this application had noted that while the drug has some effect on amyloid pathology, 10 of its 11 members … ER -