Aducanumab: Difference between revisions
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MDElliottMD (talk | contribs) Tier 1 taxonomy consolidation: removed redundant Category:Anti-dementia (canonical already present); removed redundant Category:Anti-Amyloid Antibodies (canonical already present) |
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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| classes | | uses = Alzheimer disease (FDA accelerated approval June 2021; '''withdrawn from market January 2024''' by manufacturer Biogen).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| starting_dose | | fda_max = Withdrawn 2024 | ||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| routes | | duration = Withdrawn | ||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| halflife | | pregnancy = Discontinued/withdrawn | ||
| bioavailability | | legal = Withdrawn from US market January 2024 | ||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- | [[Category:Anti-Dementia Medicines]] | ||
[[Category:Anti-Amyloid Monoclonal Antibodies]] | |||
[[Category:Alzheimer Disease Medicines]] | |||
[[Category:Withdrawn Medicines]] | |||