Aduhelm: What to Know

Overview

Aduhelm, also known by its generic name aducanumab, is an experimental drug developed by Biogen for the treatment of Alzheimer’s disease.

Approval and Controversy

- In June 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Aduhelm based on the results of a clinical trial showing it could reduce amyloid plaques in the brains of people with early-stage Alzheimer's.

- However, its approval was met with significant controversy in the medical community, with many experts expressing concerns about the drug's safety and effectiveness due to limited evidence from clinical trials.

Efficacy

- Aduhelm is a monoclonal antibody that targets amyloid-beta, a protein that forms plaques in the brain of people with Alzheimer's disease. It works by binding to amyloid-beta and promoting its removal from the brain.

- While some studies have shown that Aduhelm can reduce the levels of amyloid plaques in the brain, there is limited evidence that this leads to improved cognitive function or a slowing of the progression of Alzheimer's disease.

Side Effects

- The most common side effect of Aduhelm is amyloid-related imaging abnormality (ARIA). ARIA can cause symptoms such as headache, dizziness, nausea, confusion, and seizures. In severe cases, ARIA can be life-threatening.

- Other side effects of Aduhelm include infusion reactions, allergic reactions, and brain swelling.

Cost

- Aduhelm is very expensive, with an estimated annual cost of $56,000 per patient. This has raised concerns about the drug's affordability and the potential impact on the healthcare system.

Ongoing Research

- Despite the controversies surrounding Aduhelm, clinical trials are ongoing to further evaluate its safety and effectiveness. The FDA has required Biogen to conduct a post-approval clinical trial to provide additional data on the drug's benefits and risks.

- The results of these trials will help determine the future of Aduhelm and its role in the treatment of Alzheimer's disease.