Global Alzheimer’s Platform Foundation: Full FDA Approval of Donanemab Signifies Brighter Future

Washington D.C., July 2, 2024- Global Alzheimer’s Platform Foundation® (GAP) President John Dwyer applauds the U.S. Food and Drug Administration (FDA) for its decision granting full traditional approval of Eli Lilly and Company’s Kisunla™ (donanemab), a disease-modifying Alzheimer’s treatment for adults with early symptomatic Alzheimer’s disease (AD). 

Today, the FDA grants full approval for donanemab, following the science and providing another disease-modifying treatment to serve the Alzheimer’s community. This approval brings more choice and hope for those diagnosed with Alzheimer’s.  

GAP is proud to have participated in Trailblazer-Alz2, the rigorous study underlying today’s approval.  We are extremely grateful to the Citizen Scientists who generously volunteered in this study and that made this therapy a reality. We also owe a debt of gratitude to the hundreds of GAP-Net sites and their team members that worked tirelessly to complete the studies needed to obtain this approval.” Dwyer said. “We now have another disease modifying therapy for Alzheimer’s patients that provides patients much needed choice and hope for their families in the form of more time with loved ones. This is a good day for those living with this horrific disease, and it provides much needed options and optimism as we strive to end Alzheimer’s for all who are living with it.”

“We now look to the U.S. Centers for Medicare and Medicaid Services (CMS) to cover this safe and effective therapy for people with Alzheimer’s disease. It is imperative that this medication is covered for all, and not only those privileged enough to afford it out-of-pocket. We need to prioritize health equity and access; it is essential that this medication is available to all who can benefit from it. 


For immediate release:

About the Global Alzheimer’s Platform (GAP) Foundation:
The nonprofit Global Alzheimer’s Platform Foundation was founded to speed the
delivery of Alzheimer’s treatments with a commitment to promoting diversity in clinical
research, as well as lowering the cost and duration of clinical trials to ensure that no
one is left behind. As part of its mission, GAP supports more than 100 clinical
research sites worldwide through study start-up and recruitment activities, promoting
diversity in research studies, and giving attention to the citizen scientists who make
research possible.

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