Eisai Seeks FDA Approval for IV Maintenance Dosing of LEQEMBI® in Early Alzheimer’s Treatment

Eisai Co., Ltd. (based in Tokyo, CEO: Haruo Naito) and Biogen Inc. (headquartered in Cambridge, Massachusetts, CEO: Christopher A. Viehbacher) have jointly announced the submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA). This application pertains to monthly maintenance dosing of lecanemab-irmb, known as LEQEMBI®, administered intravenously (IV). LEQEMBI is specifically indicated for treating Alzheimer’s disease (AD) in patients at the early stages of cognitive impairment or mild dementia.

The monthly IV maintenance regimen involves patients who have completed the initial biweekly IV phase. This maintenance phase aims to sustain effective drug concentration to facilitate the clearance of highly toxic protofibrils, even after the removal of amyloid-beta (Aβ) plaques from the brain. The submission of the sBLA is supported by data modeling from various clinical studies, including Phase 2 and Clarity AD studies, along with their respective open-label extensions.

Originally, Eisai intended to submit a Biologics License Application (BLA) in March 2024 for weekly maintenance therapy via subcutaneous (SC) administration. However, in response to FDA’s request for additional immunogenicity data, Eisai planned to initiate a rolling BLA. Subsequently, the FDA specified the need for a Fast Track designation for the SC formulation to proceed with the rolling review. Eisai has complied with this requirement and submitted a request for Fast Track designation. The FDA is expected to make a decision on this within 60 days of the submission in March 2024.

Alzheimer’s disease is a progressive neurotoxic condition that starts before and continues after plaque deposition. Early intervention is crucial as it can slow down disease progression, with ongoing treatment potentially extending benefits even after plaque clearance. Timely diagnosis and treatment of Mild Cognitive Impairment (MCI) and mild AD dementia offer the best chance of benefitting patients. Maintenance dosing aims to sustain clinical and biomarker benefits with a regimen that may be more convenient for patients and caregivers.

LEQEMBI is currently approved in the U.S., Japan, and China, with applications pending review in various other regions. Eisai leads the development and regulatory submissions globally, while both companies engage in co-commercialization and co-promotion. Eisai retains final decision-making authority regarding the product.

Protofibrils, considered the most toxic form of Aβ, play a significant role in AD-related cognitive decline by causing neuronal injury. Reduction of protofibrils may prevent disease progression by minimizing neuronal damage and cognitive dysfunction.

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION LEQEMBI (lecanemab-irmb) 100 mg/ml injection for intravenous (IV) use is indicated for treating Alzheimer’s disease. Treatment initiation with LEQEMBI is recommended in patients with mild cognitive impairment or mild dementia stage, as studied in clinical trials.

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