***George Vradenburg is available for comment today live from the National Alzheimer's Summit in Washington, D.C.***

Urges Swift FDA Review On Biologics License Application to be Submitted in 2020

WASHINGTON, DC (October 22, 2019) – George Vradenburg, chairman and co-founder of UsAgainstAlzheimer’s, issued the following statement on the announcement today by Biogen and Eisai of plans to seek regulatory approval in early 2020 by the Food and Drug Administration (FDA) for aducanumab, an investigational treatment for early Alzheimer’s disease. A new analysis of a larger dataset from clinical studies showed aducanumab can reduce brain amyloid and clinical decline in patients with early Alzheimer’s disease.

“This is exciting news and a promising step toward an effective way to treat Alzheimer’s. It offers renewed hope for people living with early stages of the disease, their caregivers and families. Aducanumab could become the first therapy to reduce the clinical decline of Alzheimer’s disease and demonstrate that removing beta amyloid resulted in better clinical outcomes. We urge the FDA to conduct its review as expeditiously as possible when the application is submitted in early 2020.

“We congratulate Biogen and Eisai for this achievement and applaud their persistence in pursuing a pharmacological cure for Alzheimer’s despite earlier setbacks. We are encouraged that a new analysis of a larger dataset from the Phase III clinical studies that were discontinued in March 2019 shows that aducanumab may reduce brain amyloid and clinical decline in patients with early Alzheimer’s disease.  

“Research into drug therapies for Alzheimer’s has seen too many disappointments, and today’s announcement is a positive and much-needed sign of progress in the drive to stop this disease.”

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About UsAgainstAlzheimer’s (UsA2)

UsAgainstAlzheimer’s (UsA2) is a disruptive advocacy and research-focused organization that is pushing for expanding treatments and accelerating towards a cure for Alzheimer’s disease. UsA2’s transformative programming is laser-focused on proactive brain health across the lifespan and understanding what matters most across the lived experiences of those affected by Alzheimer’s in the service of preventing, treating and curing this disease.  We are working to ensure that all communities have their voices heard, and get a chance to be brain healthy from the earliest years while building resistance to and resilience against possible cognitive decline.