ID	DDInter2170
	Drug Type	biotech
	Protein Chemical Formula	None
	Protein Average Weight	146000.000
	CAS Number	1384260-65-4
	Description	Aducanumab, or BIIB037, is a monoclonal IgG1 antibody that targets extracellular amyloid-β plaques in the brain; similar to [gantenerumab], [bapineuzumab] and [solanezumab].[A235668,A235730] Aducanumab is a recombinant antibody derived from patients with slow or absent cognitive decline, and phase 1b clinical trial data have shown patients treated with aducanumab show a reduction in amyloid-β plaques.[A235668] Based on Mini-Mental State Examination and Clinical Dementia Rating (CDR), patients taking aducanumab showed signs of slowing progression, however, these data are controversial.[A235668,A235720] Clinical trials showed a 23% relative difference between the experimental and placebo groups as determined by CDR, however, this is equivalent to an absolute difference of 0.4/18.[A235720] Although aducanumab's approval represents the first drug treatment for Alzheimer's disease, the approval is conditional on further results.[L34420] Biogen enrolled patients in phase 3 clinical trials in 2015, but increased the size of the trials from 1350 patients to 1650 patients to maintain statistical power in the face of a high standard deviation.[A235720] Development of aducanumab was discontinued in March 2019 when two phase 3 clinical trials did not pass futility analysis, however, Biogen sought FDA approval in October 2019 after a reanalysis of the data.[A235720] Aducanumab was granted accelerated FDA approval on 7 June 2021.[L34393] Continued approval will be based on further trials confirming a clinical benefit over currently available therapy.[L34420]
	ATC Classification	N06DX03
Sequences	None
Useful Links	DrugBank PubChem Substance Wikipedia