Drug updated on 5/17/2024
| Dosage Form | Injection (intravenous; 170 mg/1.7 mL, 300 mg/3 mL) |
| Drug Class | Amyloid beta-directed antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of Alzheimer’s disease. Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Aduhelm. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
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Summary
- Aducanumab-avwa (Aduhelm) is indicated for the treatment of Alzheimer's disease, specifically in patients with mild cognitive impairment or mild dementia stage. The medication demonstrates the potential in targeting the pathophysiology of Alzheimer’s by focusing on amyloid-beta plaques and decelerating cognitive decline.
- Eighteen systematic reviews/meta-analyses were assessed to collect information about this medication. These evaluations concentrated on comparing monoclonal antibodies, including Aduhelm, for their effectiveness and safety implications in treating Alzheimer’s disease.
- In comparison to other medications like Donanemab, Lecanemab, Gantenerumab, and Solanezumab, Aduhelm is distinguished by its significant reduction of amyloid-beta plaques, which correlates with improved clinical outcomes in AD patients.
- It has been recognized that Aduhelm presents certain safety concerns related to Amyloid-related imaging abnormalities, such as edema (ARIA-E) and hemorrhage (ARIA-H), necessitating cautious patient selection and monitoring during therapy.
- Regarding population considerations based on genetic characteristics such as Apolipoprotein E ε4 status (APOE ε4), studies suggest that both Aducanumab-avwa (Aduhelm) and Donanemab might offer slightly better efficacy among carriers, indicating a need for customizing therapies according to genetic factors.
- Despite the risks associated with Amyloid-related imaging abnormalities (ARIA), evidence suggests that the benefit-to-risk ratio could be favorable, especially when robust risk management strategies are executed, including meticulous monitoring protocols, particularly among genetically predisposed populations who are at higher risk for adverse events like ARIA-E & H.
- The effectiveness comparison indicates that while all monoclonal antibodies have some level of impact on slowing cognitive decline, Aducanumab-avwa (Aduhelm)'s direct influence on reducing beta-plaques sets it apart despite having comparable levels of improvement in cognitive functions as other leading monoclonal antibodies.
- In conclusion, Aduhelm offers promise in terms of efficacy by addressing a fundamental pathophysiological aspect of Alzheimer's disease, yet it carries significant safety considerations requiring cautious patient selection and monitoring.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Aduhelm (aducanumab-avwa) Prescribing Information. | 2023 | Biogen Inc., Cambridge, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Guidelines for pharmacotherapy in Alzheimer's disease - A primer on FDA-approved drugs. | 2023 | Journal Of Neurosciences in Rural Practice |
| Aducanumab use in symptomatic Alzheimer disease evidence in focus: a report of the AAN Guidelines Subcommittee. | 2022 | Neurology |
| Aducanumab: Appropriate use recommendations. | 2021 | The Journal of Prevention of Alzheimer's Disease |