USA | The U.S. Food and Drug Administration has approved weekly dosing of Leqembi for treatment of early Alzheimer's disease across the United States.
The Alzheimer’s Association has welcomed the 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 acknowledgement 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 centre 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.
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