ALZHEIMER'S ASSOCIATION WELCOMES FDA ACTION APPROVING LEQEMBI WEEKLY SUBCUTANEOUS MAINTENANCE DOSING

CHICAGO, Aug. 29, 2025 /PRNewswire/ -- The Alzheimer's Association welcomes today's U.S. Food and Drug Administration (FDA) action to approve weekly subcutaneous maintenance dosing of Leqembi® (lecanemab, Eisai/Biogen) for early Alzheimer's disease. With this approval, Leqembi IQLIK is the first monoclonal antibody that clears amyloid beta for the treatment of early Alzheimer's disease that is approved for subcutaneous administration using an autoinjector.

Patients who have completed their 18-month treatment plan of intravenous infusions every two weeks may now be able to transition to self-administered — or caregiver-administered — weekly doses at home. The hope is that at-home administration of the treatment will be less burdensome and easier for patients and care partners to continue long-term.

"This FDA action demonstrates continued progress in the field of Alzheimer's treatment," said Maria C. Carrillo, Ph.D., Alzheimer's Association chief science officer and medical affairs lead. "We are seeing the evolution of amyloid targeting antibody treatments, including improvements in drug delivery and acknowledgment that this class of treatments continues to demonstrate clinical benefit beyond the 18-month clinical trial data."

Long-term extension studies reported in July at the Alzheimer's Association International Conference® (AAIC) 2025 showed that benefits continue to accrue with longer time on approved amyloid targeting treatments. With Leqembi, people on the treatment for four years stayed in the early stage of the disease longer — significantly slowing typical disease-based decline in memory and thinking abilities. The safety profile remained consistent with past results, with ARIA rates decreasing after the first year.

"The expectation with subcutaneous delivery of Alzheimer's treatment is that patients and care partners find it easier, simpler and more convenient to use, and that it reduces the need to travel for hospital or infusion center visits, compared to intravenous infusion," Carrillo said. "The result is that more people will continue taking their medicine and experiencing treatment benefits."

As we continue to make progress with early detection and treatment of Alzheimer's and other diseases that cause dementia, the Alzheimer's Association believes we need more real-world data on actual long-term use of these treatments in the community, in addition to controlled clinical trials. Both are important to increase the understanding of clinicians, patients, researchers, drug developers, payers and regulators about the evolving landscape of treatment.

Participation in the Alzheimer's Association's Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) by clinicians and patients is encouraged by the FDA in the Leqembi prescribing information. ALZ-NET is collecting clinical and safety data for patients treated with new FDA-approved Alzheimer's disease therapies, and tracking the long-term health outcomes associated with their use in real-world settings. The evidence gathered will be used to advance research, improve health equity and patient care, and inform Alzheimer's and other dementia treatment practices. For more information on ALZ-NET, or to inquire about participating, please visit https://www.alz-net.org

About the Alzheimer's AssociationThe Alzheimer's Association is a worldwide voluntary health organization dedicated to Alzheimer's care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. Visit alz.org or call 800.272.3900.

SOURCE Alzheimer's Association