Aducanumab - Revision history

MDElliottMD: Tier 1 taxonomy consolidation: removed redundant Category:Anti-dementia (canonical already present); removed redundant Category:Anti-Amyloid Antibodies (canonical already present)

2026-05-21T17:01:51Z

Tier 1 taxonomy consolidation: removed redundant Category:Anti-dementia (canonical already present); removed redundant Category:Anti-Amyloid Antibodies (canonical already present)

← Older revision		Revision as of 17:01, 21 May 2026
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	[[Category:Anti-Dementia Medicines]]		[[Category:Anti-Dementia Medicines]]
	~~[[Category:Anti-dementia]]~~
	[[Category:Anti-Amyloid Monoclonal Antibodies]]		[[Category:Anti-Amyloid Monoclonal Antibodies]]
	~~[[Category:Anti-Amyloid Antibodies]]~~
	[[Category:Alzheimer Disease Medicines]]		[[Category:Alzheimer Disease Medicines]]
	[[Category:Withdrawn Medicines]]		[[Category:Withdrawn Medicines]]

MDElliottMD: Em-dash sweep: replace em-dash with comma per project rule; PendellsCorner verbatim quotes preserved.

2026-05-19T03:16:04Z

Em-dash sweep: replace em-dash with comma per project rule; PendellsCorner verbatim quotes preserved.

Maintenance script: Expand Aducanumab with Stahl-sourced detail (with skepticism)

2026-05-16T02:03:46Z

Expand Aducanumab with Stahl-sourced detail (with skepticism)

← Older revision		Revision as of 02:03, 16 May 2026
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	{{MedTemplate		{{MedTemplate
	~~\| generic = Aducanumab~~		\| brand = Aduhelm
	\| brand = Aduhelm		\| classes = Anti-amyloid beta (Aβ) monoclonal antibody
	~~\| structure =~~		\| 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classes = Anti-~~dementia, Monoclonal~~ antibody		\| uses = Alzheimer disease (FDA accelerated approval June 2021; '''withdrawn from market January 2024''' by manufacturer Biogen).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 = ~~Amyloid~~-~~beta~~ plaque-~~clearing antibody~~		\| 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	\| starting_dose =		\| fda_max = Withdrawn 2024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.
	~~\| pharmacokinetics =~~		\| 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.
	~~\| indications =~~		\| interactions = <pharmaInteractions/>
	~~\| dosing~~ =
	\| effects =
	\| interactions = <pharmaInteractions/>
	~~\| pregnancy_details =~~
	~~\| monitoring =~~
	~~\| counseling =~~
	~~\| anecdotes =~~
	~~\| seealso =~~
	~~\| references =~~
	}}		}}


	[[Category:Anti-Dementia Medicines]]		[[Category:Anti-Dementia Medicines]]
	[[Category:Anti-dementia]]		[[Category:Anti-dementia]]
	[[Category:Anti-Amyloid Monoclonal Antibodies]]		[[Category:Anti-Amyloid Monoclonal Antibodies]]
			[[Category:Anti-Amyloid Antibodies]]
			[[Category:Alzheimer Disease Medicines]]
			[[Category:Withdrawn Medicines]]

MDElliottMD: Comprehensive categorization: +Anti-Amyloid Monoclonal Antibodies

2026-05-15T18:42:22Z

Comprehensive categorization: +Anti-Amyloid Monoclonal Antibodies

← Older revision		Revision as of 18:42, 15 May 2026
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	[[Category:Anti-Dementia Medicines]]		[[Category:Anti-Dementia Medicines]]
	[[Category:Anti-dementia]]		[[Category:Anti-dementia]]
			[[Category:Anti-Amyloid Monoclonal Antibodies]]

MediaWiki default: Assign pharmacological categories from List_of_CNS-active_medicines

2026-05-14T15:07:06Z

Assign pharmacological categories from List_of_CNS-active_medicines

← Older revision		Revision as of 15:07, 14 May 2026
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	}}		}}


			[[Category:Anti-Dementia Medicines]]
	[[Category:Anti-dementia]]		[[Category:Anti-dementia]]

MDElliottMD: Pharmacopedia: add

2026-05-14T03:30:41Z

Pharmacopedia: add <pharmaInteractions/>

← Older revision		Revision as of 03:30, 14 May 2026
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	\| dosing =		\| dosing =
	\| effects =		\| effects =
	\| interactions =		\| interactions = <pharmaInteractions/>
	\| pregnancy_details =		\| pregnancy_details =
	\| monitoring =		\| monitoring =

MDElliottMD: Pharmacopedia: remove contraindications parameter

2026-05-14T02:40:22Z

Pharmacopedia: remove contraindications parameter

← Older revision		Revision as of 02:40, 14 May 2026
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	\| dosing =		\| dosing =
	\| effects =		\| effects =
	~~\| contraindications =~~
	\| interactions =		\| interactions =
	\| pregnancy_details =		\| pregnancy_details =

MDElliottMD: Added empty fda_max parameter to MedTemplate call

2026-05-13T02:32:54Z

Added empty fda_max parameter to MedTemplate call

← Older revision		Revision as of 02:32, 13 May 2026
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	\| starting_dose =		\| starting_dose =
	\| preparations =		\| preparations =
			\| fda_max =
	\| routes =		\| routes =
	\| onset =		\| onset =
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	[[Category:Anti-dementia]]		[[Category:Anti-dementia]]

MDElliottMD: Expand stub to full MedTemplate parameter set

2026-05-13T01:00:00Z

Expand stub to full MedTemplate parameter set

@@ Line 1: / Line 1: @@
 {{MedTemplate
-| generic           = Aducanumab
+| generic            = Aducanumab
-| brand             = Aduhelm
+| brand              = Aduhelm
-| classes           = Anti-dementia, Monoclonal antibody
+| structure          =
-| mechanism         = Amyloid-beta plaque-clearing antibody
+| classes            = Anti-dementia, Monoclonal antibody
 }}
 [[Category:Anti-dementia]]

MDElliottMD: Auto-created stub

2026-05-13T00:00:00Z

Auto-created stub

New page

{{MedTemplate
| generic = Aducanumab
| brand = Aduhelm
| classes = Anti-dementia, Monoclonal antibody
| mechanism = Amyloid-beta plaque-clearing antibody
}}
[[Category:Anti-dementia]]

← Older revision		Revision as of 03:16, 19 May 2026
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	\| brand = Aduhelm		\| brand = Aduhelm
	\| classes = Anti-amyloid beta (Aβ) monoclonal antibody		\| 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.		\| 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.
	\| 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.		\| 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.
	\| starting_dose = Was 1 mg/kg IV q4w × 2, then 3 mg/kg × 2, then 6 mg/kg × 2, then 10 mg/kg q4w		\| starting_dose = Was 1 mg/kg IV q4w × 2, then 3 mg/kg × 2, then 6 mg/kg × 2, then 10 mg/kg q4w
Line 14:		Line 14:
	\| pregnancy = Discontinued/withdrawn		\| pregnancy = Discontinued/withdrawn
	\| legal = Withdrawn from US market January 2024		\| legal = Withdrawn from US market January 2024
	\| 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.		\| 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.

	'''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.		'''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= IgG1 monoclonal antibody binding aggregated Aβ (oligomers and fibrils) at the N-terminus. Promotes microglial Aβ clearance via Fc-receptor binding.
	\| 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.		\| 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/>		\| interactions = <pharmaInteractions/>
	}}		}}