Alzheimer’s Drug Discovery Foundation Statement on Biogen Announcement to Plan FDA Filing of Aducanumab for Alzheimer’s Disease

The Alzheimer’s Drug Discovery Foundation is encouraged by today’s announcement from Biogen of its plans to seek regulatory approval for aducanumab as a potential new treatment for Alzheimer’s disease, particularly for people living with the early stages of Alzheimer’s. 

According to Biogen, new data showed a subset of patients who received a higher dose of aducanumab experienced significant slowing of decline on measures of cognition and activities of daily living, such as household chores. New data also showed positive changes in biomarkers.

This news comes after Biogen’s announcement last March that it was discontinuing Phase 3 clinical trials of aducanumab due to “futility analysis” of data. The trial for aducanumab – which was designed to slow the progression of Alzheimer’s by removing beta-amyloid plaques from the brain – evaluated the efficacy and safety of aducanumab in patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer’s disease dementia.  

"In the earlier phases of clinical development, I had hope for this study," said Howard Fillit, MD, Founding Executive Director and Chief Science Officer at the ADDF. "It was one of the first clinical trials to use amyloid PET imaging to ensure the study participants had Alzheimer's disease showing the importance of developing better biomarkers to improve the rigor of trial design. We need to see more data to evaluate the real strengths and weaknesses of the study. We look forward to receiving further analyses in the coming months.  It is certainly too early to tell if aducanumab will be approved, but it is encouraging the FDA has agreed to review the drug application for possible approval.

Today's news must be taken in context of the overall goal of finding better ways to detect and treat Alzheimer's disease. There are over 100 drugs in clinical trials for Alzheimer’s disease with the majority focused on novel targets, according to a recent ADDF clinical trial report. The ADDF has long supported a broader approach that champions the biology of aging, which targets multiple aging pathways, such as inflammation, vascular problems, metabolic and mitochondrial changes, and epigenetics.”

“While we await review of further data, we need to keep in mind that we are dealing with a complicated disease that can be caused by many factors,” said Dr. Fillit. Like other diseases of aging including cancer, diabetes and heart disease, it is likely a combination of drugs addressing multiple target pathways will be needed to effectively treat Alzheimer’s. Combination therapy through precision medicine is ultimately the goal."