PT  - JOURNAL ARTICLE
AU  - Katherine Coerver
AU  - Melissa M. Yu
AU  - Anelyssa D'Abreu
AU  - Marc Wasserman
AU  - Kavita V. Nair
TI  - Practical Considerations in the Administration of Aducanumab for the Neurologist
AID  - 10.1212/CPJ.0000000000001144
DP  - 2022 Apr 01
TA  - Neurology: Clinical Practice
PG  - 169--175
VI  - 12
IP  - 2
4099  - http://cp.neurology.org/content/12/2/169.short
4100  - http://cp.neurology.org/content/12/2/169.full
AB  - Aducanumab (Aduhelm), developed by the biotechnology firm Biogen in Cambridge, MA, 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 disease (AD), the FDA updated aducanumab's labeling on July 8, 2021, for “treatment in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.”5 With 6 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