Subjects ” Alzheimer’s and dementia
The Food and Drug Administration (FDA) has approved an updated label for Aduhelm ™ (aducanumab-avwa) to include additional information about the populations studied in the clinical trials.
The section “Indications and Use” now states that treatment with Aduhelm should be started in patients with mild cognitive impairment or mild dementia, the population in which treatment was started in clinical trials. The safety or effectiveness of initiating treatment in earlier or later stages of the disease has not been studied.
Aduhelm is a human monoclonal antibody obtained from a de-identified library of B cells obtained from healthy elderly patients with no evidence of cognitive impairment or from cognitively impaired elderly patients with unusually slow cognitive decline. The treatment, given as a monthly intravenous infusion (every 4 weeks at least 21 days apart), binds to aggregated β-amyloid and promotes the removal of amyloid from the brain.
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In June 2021, the FDA granted Aduhelm accelerated approval based on a surrogate endpoint, which in Aduhelm’s case was amyloid beta plaque reduction, contrary to the recommendations of its advisory panel. Three members of the FDA’s Advisory Committee on Drugs of the Peripheral and Central Nervous System then resigned for approval. Two committees of the House of Representatives have launched an investigation into the controversial approval and the high price of the drug.
reference
FDA approves updated Aduhelm ™ prescribing information to highlight the population studied in clinical trials. [press release]. Cambridge, MA and Tokyo, Japan: Biogen and Eisai Co., Ltd .; July 8, 2021.
This article originally appeared on MPR
Subjects:
Treatment of Alzheimer’s disease and dementia for cognitive impairment
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