Biogen Alzheimer’s Drug Alzheimer’s is a devastating disease that affects millions of people worldwide.
Currently, there is no known cure. In October 2020, US regulators decided to review Biogen’s drug aducanumab for possible approval, raising the possibility of a new treatment option for Alzheimer’s patients.
What is Biogen’s Alzheimer’s Drug, Aducanumab?
Biogen’s Alzheimer’s drug, Aducanumab, is an experimental monoclonal antibody designed to reduce the amount of a toxic protein known as amyloid beta. Amyloid beta is believed to play a major role in the development of Alzheimer’s. By reducing the amount of amyloid beta in the brain, it is hoped that aducanumab will slow or even stop the progression of Alzheimer’s, giving people with Alzheimer’s more years of quality life.
What We Know about Aducanumab
- Aducanumab is an investigational drug. It is not yet approved, but it has undergone Phase 3 clinical trials, the final step of the drug approval process.
- Aducanumab is administered by a monthly infusion and has to be taken long-term.
- Aducanumab has shown promising results in clinical trials. In one large-scale study, people with early-stage Alzheimer’s who received aducanumab experienced significantly less decline on cognitive tests compared to those who were given a placebo.
- Aducanumab is one of the few Alzheimer’s drugs being studied that targets the underlying biology of the disease. Currently, most approved Alzheimer’s drugs are only approved as symptomatic therapies, meaning they treat the symptoms of the disease rather than slowing down its progression.
Benefits of Aducanumab
- Aducanumab could slow or even stop the progression of Alzheimer’s.
- Aducanumab is designed to target the underlying biology of Alzheimer’s, not just the symptoms.
- Aducanumab may help preserve cognitive and functional abilities in people with mild Alzheimer’s.
- Aducanumab could provide more time to patients and their loved ones while they prepare for the eventual outcome.
Potential Risks and Side Effects
- The most common side effects reported in clinical trials include headaches, falls, upset stomach and a type of brain swelling known as ARIA (amyloid-related imaging abnormalities).
- There is a risk of an allergic reaction to the drug, although these are typically mild.
- In one study, a small number of patients developed serious brain infections that required hospitalization.
Regulatory Status
- Aducanumab is currently under review by the US Food and Drug Administration (FDA) and a decision is expected by March 2021.
- The FDA granted aducanumab priority review in January 2021 and will make its decision after the results of a later Phase 3 study are released.
Aducanumab is an experimental Alzheimer’s drug that is still in development. It is designed to target the underlying biology of the disease, which could slow or even stop its progression. While it has seen promising results in clinical trials, there are still many unknowns. It is not yet approved but is currently under review by the US FDA and a decision is expected by March 2021. If approved, aducanumab could be a major breakthrough in the fight against Alzheimer’s, providing a much-needed hope for those affected by this devastating disease.
