PROVIDENCE – An investigational Alzheimer’s disease drug studied extensively in Rhode Island has been submitted to the U.S. Food and Drug Administration for approval.
The drug, aducanumab, was administered to participants in clinical trials across the country, including at Butler Hospital and Rhode Island Hospital. The two hospitals contributed the highest number of participants in the studies, according to Biogen and Eisai Co. Ltd., the drug’s makers.
The companies have submitted a biologics license application to the FDA, along with a request for a priority review. A decision on whether the agency will accept the drug makers’ application for review and priority request is expected within 60 days.
Aducanumab targets amyloid plaque in the brain, which researchers say is a significant cause of cognitive decline experienced by people with Alzheimer’s disease.
If approved, the drug would become the first to help slow symptoms of the disease, and would also be the first treatment to show the benefit of removing amyloid plaque from patients’ brains.
“The submission of aducanumab for FDA approval represents a milestone in the fight against Alzheimer’s disease and we are excited that so many Rhode Islanders contributed to making this happen,” said Dr. Stephen Salloway, director of neurology and the Memory and Aging Program at Butler Hospital.
Salloway served as co-chair of the global investigator steering committee during two phase three aducanumab studies known as EMERGE and ENGAGE.
“For many people living with the early stages of Alzheimer’s disease, maintaining independence for as long as possible is the ultimate goal. 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,” he said.
Clinical trials of aducanumab focused on patients in the early stages of Alzheimer’s. Participants experienced a slowdown in loss of cognitive capability, as well as their ability to perform household chores and leave home on their own.
“If approved by the FDA, aducanumab would be the long-awaited first therapy to slow the progression of Alzheimer’s disease, and a significant achievement given that no new medication has been approved in the Alzheimer’s disease field since 2003,” said Dr. Jonathan Drake, associate director of the Alzheimer’s Disease and Memory Disorders Center at Rhode Island Hospital.
Elizabeth Graham is a PBN contributing writer.
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