#United States #FDA #Stockholm #Leqembi #Alzheimer's

FDA Grants Approval for Leqembi's Subcutaneous Dosing

On January 13, 2025, BioArctic AB announced that the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for Leqembi® (lecanemab-irmb), expanding its use for maintenance dosing via subcutaneous autoinjector (SC-AI). This approval represents a significant milestone in the treatment of Alzheimer's disease (AD), allowing for at-home administration.

The Significance of Leqembi's Approval

Leqembi is recognized as the only FDA-approved anti-amyloid therapy that may offer the convenience of subcutaneous administration, which patients can perform from the comfort of their homes. Currently indicated for patients with Mild Cognitive Impairment (MCI) or early-stage mild dementia, Leqembi aims to slow disease progression and enhance quality of life for those affected by Alzheimer’s. The anticipated Prescription Drug User Fee Act (PDUFA) action date is set for August 31, 2025, marking a crucial period for potential approval of this innovative therapy.

Enhancements in Administration Process

The newly accepted SC-AI dosing regimen is designed for individuals who have successfully completed the initial intravenous (IV) dosing schedule. The expected injection time is approximately 15 seconds, allowing for quick and efficient administration of the treatment.

Patients will receive a 360 mg weekly maintenance dose, which is predicted to maintain both clinical benefits and biomarker improvements. This advancement may significantly reduce the burden of healthcare visits, as it eliminates the need for regular hospital or infusion site trips, promoting adherence and improving patient experience.

Existing Approvals and Global Reach

Leqembi is already available in various markets, including the U.S., Japan, China, Great Britain, and others. In November 2024, it received a favorable opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending its approval in Europe. This global presence underscores the growing recognition of Leqembi's role in managing Alzheimer’s disease effectively.

Research Backing and Future Endeavors

The BLA submission is grounded in data from the Clarity AD study, an open-label extension trial demonstrating the efficacy of lecanemab. If approved, the use of Leqembi as a subcutaneous treatment will position it uniquely as a home treatment option, potentially revolutionizing how Alzheimer's disease is managed in its early stages.

Ongoing studies, such as the AHEAD 3-45 and Tau NexGen trials, reflect a continued commitment to understanding and addressing Alzheimer's through innovative solutions. These initiatives involve collaboration between BioArctic, Eisai, and various research bodies, paving the way for novel therapeutic options.

About BioArctic and Its Collaboration with Eisai

BioArctic AB, a Swedish biopharmaceutical firm, specializes in developing advanced treatments for neurodegenerative diseases. With over 15 years of collaboration with Eisai, BioArctic has been pivotal in bringing Leqembi to the market, a testament to their dedication to combating Alzheimer’s disease. BioArctic handles the commercialization of lecanemab in the Nordic regions, while Eisai oversees global distribution and regulatory approval processes.

As these developments unfold, Leqembi’s acceptance for subcutaneous administration represents a beacon of hope for patients and caregivers navigating the complexities of Alzheimer’s treatment. The transition to at-home care not only elevates the treatment experience but also emphasizes the importance of innovative solutions in addressing chronic conditions effectively.

For more information regarding Leqembi and its application in Alzheimer’s treatment, please refer to the official channels and publications from BioArctic and Eisai.