RT Journal Article
SR Electronic
T1 Practical Considerations in the Administration of Aducanumab for the Neurologist
JF Neurology: Clinical Practice
FD Lippincott Williams & Wilkins
SP 169
OP 175
DO 10.1212/CPJ.0000000000001144
VO 12
IS 2
A1 Katherine Coerver
A1 Melissa M. Yu
A1 Anelyssa D'Abreu
A1 Marc Wasserman
A1 Kavita V. Nair
YR 2022
UL http://cp.neurology.org/content/12/2/169.abstract
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