Practical Considerations in the Administration of Aducanumab for the Neurologist

Aducanumab (Aduhelm®), developed by the biotechnology firm Biogen in Cambridge, Massachusetts, was approved using the less common accelerated approval pathway by the Federal Drug Administration (FDA) reserved for treatments that fill a significant unmet need.1 Its approval on June 7, 2021 has been met with an outpouring of opinions from prescribers, insurers, advocacy groups and hospital systems regarding its risk benefit profile.2-4 Originally approved for all forms of Alzheimer’s disease (AD), the FDA updated aducanumab’s labeling on July 8th, 2021 for “treatment in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.5 With six million people nationally in the United States who suffer from AD and an anticipated one third of those who may now fulfill the criteria under the revised labeling, the implications of aducanumab’s approval continue to generate national interest.6