The FDA’s approval comes following the recommendation of an FDA advisory committee, which voted unanimously for Leqembi’s full approval earlier this month
WASHINGTON, DC, July 6, 2023 — Following a decision from the U.S. Food and Drug Administration (FDA) granting full traditional approval to Leqembi, a disease-modifying Alzheimer’s treatment from Eisai, Global Alzheimer’s Platform Foundation® (GAP) President John Dwyer applauds the FDA for its decision.
“The FDA met its congressional mandate today in granting full approval for Leqembi. The approval follows the science, and it serves the Alzheimer’s community, which has been waiting for a disease-modifying treatment for decades. We are also grateful to Eisai’s tireless efforts to discover this therapy and to the thousands of Alzheimer’s patients who participated in the clinical studies that lead to this result,” Dwyer said. “This gives those living with the horrible effects of Alzheimer’s and their families hope for a better future.”
“We now look to the U.S. Centers for Medicare and Medicaid Services (CMS) to immediately pay for this safe and effective therapy for Medicare patients living with Alzheimer’s disease just like they do for any other drug. We expect nothing less than coverage to label,” Dwyer added. “Failure to cover these medications and those like it leave hope only to the privileged few who can afford it and would increase health disparities among our hardest hit by this disease, including those who are Black or Hispanic.”
Previously, Dwyer noted the impact of the promising data from the Phase 3 study for Leqembi, also known as lecanemab, for meeting all of its study endpoints. He said, “The millions-strong Alzheimer’s community deserves access to treatments that improve their lives and slow progression of this insidious disease. I am proud that GAP and GAP-Net clinical research trial sites were integral in conducting this groundbreaking study,” he added.
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About GAP Foundation
The Global Alzheimer’s Platform Foundation® (GAP) is a patient-centered nonprofit organization dedicated to accelerating the delivery of innovative therapies for neurological disorders by reducing the duration and cost of clinical trials. Over 100 research centers around the world are part of the growing GAP Network (GAP-Net).