Aducanumab is an investigative drug therapy for treating Alzheimer’s disease from Biogen, an American biotechnology company based in Cambridge, Massachusetts.
Last month, the U.S. Food and Drug Administration granted aducanumab priority review, which means the FDA will render a decision no later than March 7.
In early July, Biogen said in a news release and also during a presentation at the virtual 2020 Alzheimer’s Association International Conference that if aducanumab is approved by the FDA, it would be the first treatment with the potential to meaningfully change the course of Alzheimer’s disease.
Aducanumab was originally developed by the biopharmaceutical company Neurimune, which entered into partnership with Biogen in 2007, and Biogen later gained the license for further development. Biogen has since collaborated with the pharmaceutical company Eisai to advance the clinical studies of the drug, which have been conducted since 2017.
Alzheimer’s disease is a progressive neurological condition that currently cannot be prevented, delayed or cured. Current therapies for the disease provide only short-term treatment of cognitive symptoms but do not change the course of the disease. The disease is characterized by deposits of proteins known as amyloid plaques in the brain, which accumulate into clumps that lead to eventual cell death during the progression of the disease.
Aducanumab is an antibody that targets these plaques and binds to the amyloid clumps and through this interaction, the drug could reduce or remove the number of the amyloid plaques present in the brain, which ultimately may slow neurodegeneration and disease progression.
During the clinical development of aducanumab, Biogen conducted two Phase 3 trials, called "Emerge" and "Engage," in patients with early stage Alzheimer’s disease.
In the Emerge research, patients receiving the drug experienced a significant slowdown of decline in cognition and functions, such as memory, orientation and language. There were also significant slowdowns in the decline on activities of daily living, such as common household chores, shopping or conducting personal finances.
While the Engage research did not meet its primary endpoint, Biogen researchers believe a subset of data from it can be supportive of the Emerge outcome.
“For many people living with the early stages of Alzheimer’s disease, maintaining independence for as long as possible is the ultimate goal,” noted Dr. Stephen Salloway, director of Butler Hospital Memory and Aging Program at Brown University. “If we can help slow the progression from one stage to the next, this could preserve independence, which, in turn, could have truly meaningful benefits for people living with the disease and their loved ones. Aducanumab represents a potential breakthrough that we hope will provide a treatment foothold in the fight against Alzheimer’s disease.”