First disease-modifying drug in 16 years to be submitted for FDA approval in 2020
***John Dwyer is available for comment today live from the National Alzheimer’s Summit in Washington, D.C.***
Washington, DC (October 22, 2019) – The President of the Global Alzheimer’s Platform Foundation (GAP), John Dwyer, issued the following statement on the announcement today by Biogen and Eisai that a new analysis of a larger dataset from clinical studies showed the investigational drug aducanumab can reduce brain amyloid and clinical decline in patients with early Alzheimer’s disease. The companies plan to seek regulatory approval by the Food and Drug Administration (FDA) for aducanumab in early 2020.
Congratulations to Biogen and Eisai for the exciting finding that aducanumab reduced clinical decline in patients with early Alzheimer’s disease on multiple measures of the drug’s effectiveness. We applaud Biogen and Eisai’s rigor in analyzing the data from their clinical research in the face of previous disappointments.
It is thrilling to hear that patients who received aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation, and language. These promising findings are a credit not only to the professional researchers who conducted the study, but also to the people who volunteered their time to participate in clinical trials as ‘Citizen Scientists.’ These encouraging results have significant implications for similar approaches that target beta amyloid and more research volunteers will be needed.
The nearly six million Americans with Alzheimer’s and their families deserve for no scientific stone to go unturned in the search for a cure. The promising results of Biogen and Eisai’s persistence indicate we may need to look under some stones more than once.
About the Global Alzheimer’s Platform Foundation (GAP) The Global Alzheimer’s Platform Foundation (GAP) is a patient-centric nonprofit dedicated to speeding the delivery of innovative medicines to those in need by reducing the time and cost of Alzheimer’s disease clinical trials. In collaboration with other foundations, research centers and industry, GAP established GAP-Net, a growing network of 73 academic and private Alzheimer’s disease research centers. GAP-Net sites share data, best practices, use of a central Institutional Review Board and common clinical trial contracts. GAP and GAP-Net are committed to disrupting clinical trial recruitment and study processes and to reducing clinical testing cycles by up to two years. GAP is a 501c3 organization. To learn more about GAP, please visit: www.globalalzplatform.org