Drug updated on 5/3/2024
| 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).
Summary
- Aducanumab-avwa (Aduhelm) is a disease-modifying anti-amyloid-beta human monoclonal antibody used for the treatment of Alzheimer's disease.
- According to nine systematic reviews and meta-analyses, aducanumab has been reported to reduce brain amyloid-beta plaques in a time-and dose-dependent manner, slow cognitive decline by 22% in high-dose treated groups, and decrease plasma p181-tau levels.
- The drug was found more effective than angiotensin-receptor blockers (ARBs), with fewer side effects noted for ARBs compared to aducanumab; however, lithium may be more cost-effective than aducanumab for treating mild cognitive impairment and Alzheimer's disease according to one network meta-analysis study.
- Adverse events associated with this drug include Amyloid Related Imaging Abnormalities (ARIA), which were profound in high-dose treated group; Apolipoprotein E gene's fourth allele status could potentially influence patient selection due its association with increased risk of ARIA.
- Three other anti-amyloid immunotherapies - lecanemab, donanemab and solanezumab - are also being studied as potential treatments for Alzheimer’s Disease; they have shown relative efficacy in terms of cognitive function improvement but their clinical relevance remains questionable after 18 months due to significant occurrence of adverse events such as ARIA-E or hemorrhage risks.
- Despite some promising results from trials on antibodies against beta-Amyloids including aducanumb-avwa (Aduhelm), there is still need for further studies addressing the long-term safety profile and efficacy outcomes before confirming that benefits outweigh risks associated with these therapies especially considering their current costs versus clinical benefits alignment issues raised by preliminary medico-economical analyses data available so far.
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 |