Alzheimer's Association Applauds FDA Approval for Weekly Leqembi Dosing

On August 29, 2025, the Alzheimer's Association expressed enthusiasm for the recent decision by the U.S. Food and Drug Administration (FDA) to approve weekly subcutaneous maintenance dosing of Leqembi® (lecanemab), specifically aimed at treating early stages of Alzheimer's disease. This important milestone positions Leqembi as the first monoclonal antibody treatment that effectively removes amyloid beta, now available for administration at home via an autoinjector.

Previously, patients undergoing this regimen were required to undergo intravenous infusions every two weeks for 18 months. The shift to self-administered or caregiver-supported weekly doses is anticipated to significantly alleviate the burden for both patients and their caregivers, facilitating long-term treatment compliance.

Dr. Maria C. Carrillo, the chief science officer at the Alzheimer's Association, stated, "This FDA action serves as a testament to the ongoing advancements in Alzheimer’s treatment. It signals an evolution in amyloid-targeting antibody therapies, showcasing enhancements in drug delivery methods and affirming the sustained clinical benefits these treatments offer beyond just the initial trial findings."

Insights from recent long-term extension studies presented at the Alzheimer’s Association International Conference (AAIC) 2025 shed light on the therapy's continued efficacy. Individuals engaging with Leqembi for a span of four years observed a notable slowdown in the cognitive decline typically associated with Alzheimer's disease, allowing them to remain in the early stages of the condition for more extended periods. Moreover, safety data indicated a consistent risk profile, with reported instances of ARIA (Amyloid-Related Imaging Abnormalities) decreasing after the first year of treatment.

The switch to subcutaneous delivery is expected to streamline the treatment process for patients and care partners alike, minimizing the need for regular hospital visits. Dr. Carrillo elaborated, "With this enhanced mode of administration, the objective is to make it easier and more convenient for patients to adhere to their treatment protocols, leading to improved health outcomes."

However, the Alzheimer’s Association stresses the necessity for further real-world data regarding the long-term use of these therapies in clinical practice. Gathering such insights is crucial for fostering a comprehensive understanding among healthcare providers, patients, researchers, and regulatory bodies about the dynamic landscape of Alzheimer’s treatments.

The FDA encourages the participation of healthcare professionals and patients in the Alzheimer’s Association's network, known as Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET). This program is pivotal in accumulating valuable clinical and safety data from patients receiving new FDA-sanctioned Alzheimer therapies and monitoring the long-term health impacts linked to their use outside clinical trials. The results compiled will propel research advancements, foster health equity, enhance patient care, and refine treatment strategies for Alzheimer’s and dementia.

For those interested in learning more about ALZ-NET or wishing to participate, additional information is available at ALZ-NET.

About the Alzheimer's Association

The Alzheimer's Association is a global voluntary health organization committed to advancing care, support, and understanding around Alzheimer’s disease. The organization’s mission is to pioneer efforts aimed at ending Alzheimer’s and all other forms of dementia through expedited global research initiatives, encouraging risk reduction, early detection, and advancing the quality of patient care and support. Their vision is clear—creating a world free from Alzheimer’s and all related dementia conditions. More details can be accessed at alz.org or by contacting 800.272.3900.