Aducanumab

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

Aducanumab, or BIIB037, is a monoclonal IgG1 antibody that targets extracellular amyloid-β plaques in the brain; similar to gantenerumab, bapineuzumab and solanezumab. Aducanumab 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 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.

Trade Name Aducanumab
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
Aducanumab
Aducanumab

Uses

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

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

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

How Aducanumab 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 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 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.

Food Interaction

No interactions found.

Aducanumab Disease Interaction

Moderate: brain hemorrhage

Volume of Distribution

The volume of distribution of aducanumab is 9.63 L.

Elimination Route

A 10 mg/kg intravenous dose of aducanumab reached a Cmax of 182.7 µg/mL, with a Tmax of 3.0 hours, and an AUCinf of 31,400 h*µg/mL.

Half Life

The terminal half life of aducanumab is 24.8 days.

Clearance

A 10 mg/kg intravenous dose of aducanumab has a clearance of 0.39 mL/h/kg.

Elimination Route

Monoclonal IgG is predominantly eliminated by catabolism to individual amino acids that are either recycled in the body or metabolized for energy.

Innovators Monograph

You find simplified version here Aducanumab

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