Aducanumab-avwa

Aducanumab-avwa Uses, Dosage, Side Effects, Food Interaction and all others data.

Aducanumab-avwa, or BIIB037, is a monoclonal IgG1 antibody that targets extracellular amyloid-β plaques in the brain; similar to gantenerumab, bapineuzumab and solanezumab. Aducanumab-avwa is a recombinant antibody derived from patients with slow or absent cognitive decline, and phase 1b clinical trial data has shown patients treated with aducanumab show a reduction in amyloid-β plaques. Based on Mini-Mental State Examination and Clinical Dementia Rating (CDR), patients taking aducanumab showed signs of slowing progression, however these data are controversial. 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.

Although aducanumab's approval represents the first drug treatment for Alzheimer's disease, the approval is conditional on further results. 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. 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 reanalysis of the data.

Aducanumab-avwa was granted accelerated FDA approval on 7 June 2021. Continued approval will be based on further trials confirming a clinical benefit over currently available therapy.

Aducanumab-avwa
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Trade Name	Aducanumab-avwa
Availability	Prescription only
Generic	Aducanumab
Aducanumab Other Names	Aducanumab, aducanumab-avwa
Related Drugs	donepezil, memantine, Aricept, Namenda, rivastigmine, Exelon
Type
Weight	146000.0 Da (Approximate)
Groups	Approved, Investigational
Therapeutic Class
Manufacturer
Available Country
Last Updated:	September 19, 2023 at 7:00 am

Uses

Aducanumab-avwa is a monoclonal antibody indicated in the treatment of Alzheimer's disease.

Aducanumab-avwa is indicated in the treatment of Alzheimer's disease.

Aducanumab-avwa is also used to associated treatment for these conditions: Alzheimer's Disease (AD)

How Aducanumab-avwa works

Alzheimer's disease is a neurodegenerative disease. Part of the pathology of Alzheimer's disease is the presence of plaques forming extracellularly in the brain. These plaques are mostly composed of amyloid-β, a peptide of varying length formed by the cleavage of the amyloid precursor protein. The "amyloid cascade hypothesis" suggests that the accumulation of amyloid-β oligopeptides in the brain drives the pathogenesis of Alzheimer's disease.

Aducanumab-avwa is a monoclonal IgG1 antibody that binds to amyloid-β at amino acids 3-7. The amyloid-β residues Phe4, His6, Glu3, and Arg5 are responsible for the majority of the contact between amyloid-β and aducanumab's Fab region. Data from studies in mice and humans shows aducanumab treatment reduces amyloid-β, however human trials show non-significant changes in amyloid-β40 and amyloid-β42 across a dose range of 0.3-30 mg/kg and an increase in amyloid-β40 and amyloid-β42 at 60 mg/kg.

Aducanumab-avwa treatment is associated with slowing the rate of progression of Alzheimer's disease, based on Mini-Mental State Examination, Clinical Dementia Rating, and levels of p-tau in the cerebrospinal fluid.

Toxicity

Patients experiencing dose-limiting toxicity may present with amyloid-related imaging abnormalities including edema or microhemorrhages of the brain. Symptoms of dose limiting toxicity were generally transient, however patients may need to be treated with symptomatic and supportive measures.