Alzheimer’s Drug Discovery Foundation Statement on Today’s FDA Independent Panel Vote on Biogen’s Aducanumab

January 29, 2021 update: Biogen and Eisai announced today the FDA is delaying its decision on Biogen’s aducanumab, a potentially disease-modifying treatment for Alzheimer’s disease, in order to review additional clinical data submitted by the company. The ADDF strongly supports following the science and examining all available data in making what will be an important decision for patients with Alzheimer’s and their families. We look forward to the FDA’s final decision, expected by June 7.

An independent FDA advisory committee today signaled in several votes that it does not believe the clinical study data for Biogen’s aducanumab supports the drug’s approval for patients with early stage Alzheimer’s disease.

“Although today’s non-binding committee vote is not the final say, it is a reminder about the challenges of finding effective treatments for Alzheimer’s disease,” said Howard Fillit, M.D., Founding Executive Director and Chief Science Officer at the Alzheimer’s Drug Discovery Foundation (ADDF). “Drug trials are complex and do not always deliver the unequivocal answers we would like. But, one clinical trial builds on another and gives us clues to help the next.” 

The FDA’s final decision, which does not always follow the recommendation of the independent committee, is expected in early 2021. If the FDA approves aducanumab, it would be the first FDA-approved drug to modify the course of Alzheimer’s disease and slow its cognitive decline. But aducanumab, or any single drug, is unlikely to be a magic bullet.

The ADDF’s visionary approach has expanded the scientific community’s thinking from a narrow focus on a single factor, like amyloid plaques, to a broader focus on all aspects of aging (the biology of aging), the number one risk factor for Alzheimer’s disease. Alzheimer’s is a complex disease with multiple underlying causes. And just as with cancer and HIV, Dr. Fillit says Alzheimer’s will be best treated by a combination of drugs that will allow for precision medicine approaches for individual patients.

There is a diverse pipeline with over 100 drugs in clinical trials; the ADDF currently supports 20% of these drugs. Researchers have moved beyond amyloid and tau approaches and are developing potential treatments for a multitude of drug targets associated with Alzheimer’s and with aging biology, such as inflammation, vascular problems, and genetic mutations.

Dr. Fillit says there is also another important milestone in today’s meeting. “The aducanumab trial was a landmark as it was one of the first to use a biomarker test to enroll patients.” By screening participants with Amyvid™, an amyloid PET imaging test that was developed with early support from the ADDF, investigators were sure they were enrolling patients who had amyloid plaques in the brain, a hallmark of Alzheimer’s and the target of aducanumab. “Biomarkers — from PET scans and CSF fluid tests, to last week’s announcement about the first ever blood test biomarker — are ringing in a new era in Alzheimer’s drug development.”