Below is an interesting communication by our colleagues at Stanford. While various opinions are circulating, and the benefits of this drug are unclear, should you want to explore aducanumab further, please make an appointment with one of our neurologists.
Aducanumab received accelerated approval by the FDA on June 7 for the treatment of Alzheimer’s disease. This drug is a monoclonal antibody directed against amyloid, and it is administered as an intravenous infusion every 4 weeks. ‘Accelerated approval’ differs from regular FDA approval and reflects the view that there is an important unmet need for safe, effective forms of treatment for Alzheimer’s disease and related disorders.
Alzheimer’s disease is a dreadful disorder, and we know that patients and families are desperate for treatment that improves its devastating symptoms or halts its relentless progression. Aducanumab approval was based primarily on results from two large clinical trials (phase-3 trials), each lasting one and a half years.
It is clear that aducanumab reduces amyloid plaque in the brain. It was this finding that led to FDA approval. Other monoclonal antibody treatments also reduce brain amyloid but failed to provide clinical benefit and failed to gain FDA approval. We are concerned that the average clinical effect of aducanumab in the first phase-3 clinical trial was too small to be discerned by patients or family members. Results from the second phase-3 trial failed to detect even this very small effect.
The principal side effect in these trials was ARIA (Amyloid-Related Imaging Abnormalities). ARIA represents swelling or bleeding in the brain, as detected by an MRI brain scan. This side effect is usually not serious, but it can be associated with headache and confusion.
We view FDA accelerated approval of aducanumab as a symbol of hope. We are pleased that the FDA announcement states that the manufacturer will be asked to conduct post-approval studies to verify clinical benefit, which was not clearly evident in the two large phase 3 trials.
For a more detailed report on aducanamab, click this link: ICER_ALZ_Draft_Evidence_Report_050521.pdf
While this medication is not yet available, Abington Neurological Associates will continue to monitor the situation and provide updates as information becomes available. We are committed to ensuring all patients receive the best care and we remain at the forefront of clinical research to look for the best options for our patients. Please don’t hesitate to schedule an appointment to learn more about this medication and what other choices may be available to you and/or your loved ones.