Eisai and Biogen Announce FDA Acceptance of BLA for Lecanemab-irmb (US Brand Name: LEQEMBI®, China Brand Name: 樂意保®) Subcutaneous Auto-Injector (SC-AI) Weekly Maintenance Dose. Lecanemab-irmb is used to treat mild cognitive impairment and mild Alzheimer's disease (collectively referred to as early AD) caused by Alzheimer's disease (AD). The PDUFA (Prescription Drug User Fee Act) review date is set for August 31, 2025.
This Biologics License Application (BLA) is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observational data. If approved by the U.S. Food and Drug Administration (FDA), lecanemab will become an anti-amyloid therapy that can be administered at home using an auto-injector (AI), with the injection process expected to take an average of 15 seconds. As part of the weekly 360 mg maintenance dose regimen under review, patients who have completed the initial bi-weekly intravenous (IV) dosing phase will receive weekly doses, which are expected to maintain clinical and biomarker efficacy.
Alzheimer's disease (AD) is an ongoing neurotoxic process that begins before plaque deposition and continues to develop thereafter.1,2,3Lecanemab combats AD by continuously clearing fibrils and rapidly eliminating plaques. With sustained administration, lecanemab can remove highly toxic fibrils, which continue to damage neurons even after Aβ plaques have been cleared from the brain. The three-year long-term usage data presented at the Alzheimer's Association International Conference (AAIC 2024)4This suggests that early and sustained treatment may prolong the benefits of therapy even after plaques in the brain have been cleared.
SC-AI is expected to be user-friendly for patients and their care partners, reducing the number of hospital or infusion center visits and the need for intravenous care. This will make it easier for patients to continue their treatment and help further simplify the treatment pathway for AD.
Lecanemab has been approved in the United States, Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, the United Kingdom (excluding Northern Ireland), Mexico, and Macao, and marketing applications have been submitted to 17 countries and regions including the European Union (EU). In November 2024, it received a positive recommendation from the European Medicines Agency. In June 2024, the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) for the intravenous maintenance dose (IV), with the Prescription Drug User Fee Act (PDUFA) review date set for January 25, 2025.
Eisai Co., Ltd. leads the global development and registration application of lecanemab, while the product is co-commercialized and promoted by Eisai Co., Ltd. and Biogen Inc. Among them, Eisai Co., Ltd. has the final decision-making authority.
Media Contact
Public Relations Department, Eisai Co., Ltd. Tel: 03-3817-5120
Biogen Public Affairs Department Email: public.affairs@biogen.com
References
- LEQEMBI (lecanemab-irmb) injection, for intravenous use [package insert]. Nutley, NJ: Eisai Inc.
- Iwatsubo T, Irizarry M, van Dyck C, Sabbagh M, Bateman RJ, Cohen S. Clarity AD: a phase 3 placebo-controlled, double-blind, parallel-group, 18-month study evaluating lecanemab in early Alzheimer’s disease. Presented at: CTAD Conference; November 29-December 2, 2022; San Francisco, CA.
- Hampel H, Hardy J, Blennow K, et al. The amyloid-β pathway in Alzheimer’s disease. Mol Psychiatry. 2021;26(10):5481-5503.
- Eisai presents long-term administration data of lecanemab at the Alzheimer’s Association International Conference (AAIC) 2024. Available at:https://www.eisai.co.jp/ir/library/presentations/pdf/4523_240731_1.pdf
ECN-2025-0007