Aducanumab: Difference between revisions
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{{MedTemplate | {{MedTemplate | ||
| brand = Aduhelm | |||
| brand | | classes = Anti-amyloid beta (Aβ) monoclonal antibody | ||
| mechanism = Human IgG1 monoclonal antibody targeting aggregated forms of amyloid-β (Aβ) — soluble oligomers and insoluble fibrils. Reduces Aβ plaque burden on PET imaging via Fc-mediated microglial clearance. Whether plaque reduction translates to clinical benefit is the core controversy. | |||
| classes | | uses = Alzheimer disease (FDA accelerated approval June 2021; '''withdrawn from market January 2024''' by manufacturer Biogen). At time of approval indicated for MCI or mild dementia stage of AD. | ||
| mechanism | | starting_dose = Was 1 mg/kg IV q4w × 2, then 3 mg/kg × 2, then 6 mg/kg × 2, then 10 mg/kg q4w | ||
| uses | | preparations = Was: 170 mg/1.7 mL, 300 mg/3 mL vials for IV infusion | ||
| starting_dose | | fda_max = Withdrawn 2024 | ||
| preparations | | routes = IV infusion every 4 weeks | ||
| fda_max | | onset = PET Aβ reduction over months | ||
| routes | | duration = Withdrawn | ||
| onset | | halflife = ~25 days | ||
| duration | | bioavailability = 100% (IV) | ||
| halflife | | pregnancy = Discontinued/withdrawn | ||
| bioavailability | | legal = Withdrawn from US market January 2024 | ||
| pregnancy | | intro = '''Aducanumab''' (brand name Aduhelm) was an anti-amyloid-β monoclonal antibody granted FDA '''accelerated approval''' in June 2021 for Alzheimer disease — the first new AD therapy in nearly two decades. The approval was deeply controversial: three FDA advisory committee members resigned in protest, the agency overrode its own scientific advisors' recommendation, and the clinical evidence for cognitive benefit was conflicting (one phase 3 trial positive, one negative, with post-hoc analyses driving approval). Medicare ultimately limited coverage to clinical trials, severely restricting use. | ||
| legal | |||
| intro | '''Biogen withdrew aducanumab from the market in January 2024''', citing commercial reasons. The episode is widely cited as a cautionary tale about evidence standards and the persistent dominance of the amyloid cascade hypothesis even as direct evidence for clinical benefit remained weak. | ||
| pharmacodynamics= IgG1 monoclonal antibody binding aggregated Aβ (oligomers and fibrils) at the N-terminus. Promotes microglial Aβ clearance via Fc-receptor binding. | |||
| pharmacodynamics | | effects = ARIA — '''amyloid-related imaging abnormalities''' (cerebral edema or microhemorrhages on MRI), often asymptomatic but can be severe. Headache, falls, confusion. APOE ε4 carriers at substantially elevated ARIA risk. | ||
| interactions = <pharmaInteractions/> | |||
| effects | |||
| interactions | |||
}} | }} | ||
[[Category:Anti-Dementia Medicines]] | |||
[[Category:Anti-dementia]] | [[Category:Anti-dementia]] | ||
[[Category:Anti-Amyloid Monoclonal Antibodies]] | |||
[[Category:Anti-Amyloid Antibodies]] | |||
[[Category:Alzheimer Disease Medicines]] | |||
[[Category:Withdrawn Medicines]] | |||
Revision as of 02:03, 16 May 2026
Anti-amyloid beta (Aβ) monoclonal antibody
Aducanumab
Aduhelm
Aducanumab (brand name Aduhelm) was an anti-amyloid-β monoclonal antibody granted FDA accelerated approval in June 2021 for Alzheimer disease — the first new AD therapy in nearly two decades. The approval was deeply controversial: three FDA advisory committee members resigned in protest, the agency overrode its own scientific advisors' recommendation, and the clinical evidence for cognitive benefit was conflicting (one phase 3 trial positive, one negative, with post-hoc analyses driving approval). Medicare ultimately limited coverage to clinical trials, severely restricting use.
Biogen withdrew aducanumab from the market in January 2024, citing commercial reasons. The episode is widely cited as a cautionary tale about evidence standards and the persistent dominance of the amyloid cascade hypothesis even as direct evidence for clinical benefit remained weak.
IgG1 monoclonal antibody binding aggregated Aβ (oligomers and fibrils) at the N-terminus. Promotes microglial Aβ clearance via Fc-receptor binding.
Experience
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Problems
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Effects
ARIA — amyloid-related imaging abnormalities (cerebral edema or microhemorrhages on MRI), often asymptomatic but can be severe. Headache, falls, confusion. APOE ε4 carriers at substantially elevated ARIA risk.
Pharmacodynamics
Interactions
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Summary
Classes
Anti-amyloid beta (Aβ) monoclonal antibody
Common uses
Alzheimer disease (FDA accelerated approval June 2021; withdrawn from market January 2024 by manufacturer Biogen). At time of approval indicated for MCI or mild dementia stage of AD.
Pharmacy
Starting dose
Was 1 mg/kg IV q4w × 2, then 3 mg/kg × 2, then 6 mg/kg × 2, then 10 mg/kg q4w
Preparations
Was: 170 mg/1.7 mL, 300 mg/3 mL vials for IV infusion
US FDA Max
Withdrawn 2024
Pharmacology
Routes
IV infusion every 4 weeks
Onset
PET Aβ reduction over months
Duration
Withdrawn
Half-life
~25 days
Bioavailability
100% (IV)
Pregnancy
Discontinued/withdrawn
Legal status
Withdrawn from US market January 2024
Purported mechanism
Human IgG1 monoclonal antibody targeting aggregated forms of amyloid-β (Aβ) — soluble oligomers and insoluble fibrils. Reduces Aβ plaque burden on PET imaging via Fc-mediated microglial clearance. Whether plaque reduction translates to clinical benefit is the core controversy.