Drug updated on 3/28/2024
| 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
- For the treatment of Alzheimer’s disease.
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 |