Pharma Focus Asia

Eisai Submits Supplemental Biologics License Application to FDA for IV Maintenance Dosing of LEQEMBI® in Early Alzheimer's Treatment

Monday, April 01, 2024

Eisai Co., Ltd. and Biogen Inc. have jointly announced the submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for monthly intravenous (IV) maintenance dosing of lecanemab-irmb, marketed as LEQEMBI® in the U.S., for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment or mild dementia stages, collectively known as early AD.

In this proposed monthly IV maintenance regimen, patients who have completed the biweekly IV initiation phase will receive a monthly IV dose to sustain effective drug concentration. This concentration aims to facilitate the clearance of highly toxic protofibrils, which persist even after amyloid-beta (Aβ) plaque removal from the brain and continue to cause neuronal injury. The sBLA is based on observed data from Phase 2 studies (Study 201 and its open-label extension, and Clarity AD study and its OLE).

Initially, Eisai aimed to submit a Biologics License Application (BLA) for weekly maintenance therapy via subcutaneous (SC) administration by March 2024. However, in response to the FDA's requirement for additional three-month immunogenicity data at the proposed maintenance dose of 360 mg weekly, Eisai intended to initiate a rolling BLA for lecanemab SC maintenance in March 2024, under existing Fast Track and Breakthrough Therapy designations. Subsequently, Eisai was notified by the FDA of the necessity for a Fast Track designation specific to the SC formulation to proceed with rolling review. Consequently, Eisai has submitted a request for Fast Track designation for the SC formulation and plans to initiate a rolling submission if this designation is granted. The FDA will determine the Fast Track designation within 60 days of the March 2024 submission.

Alzheimer's disease is an ongoing neurotoxic process that begins before and continues after plaque deposition. Timely treatment of early AD is crucial, as it can slow disease progression, with continued treatment potentially extending benefits even after plaque clearance. Early diagnosis and treatment of Mild Cognitive Impairment (MCI) due to AD and mild AD dementia present greater opportunities for patient benefit. Maintenance dosing aims to sustain clinical and biomarker benefits with a regimen that may offer convenience for some patients and caregivers.

LEQEMBI is currently approved in the U.S., Japan, and China, with applications under review in multiple other countries. Eisai leads the global development and regulatory submissions for lecanemab, with both companies collaborating on commercialization and promotion, with Eisai retaining final decision-making authority.

Protofibrils, considered the most toxic form of Aβ, are implicated in AD-related brain injury, contributing to cognitive decline. Reduction of protofibrils may prevent AD progression by mitigating neuronal damage and cognitive dysfunction.

LEQEMBI (lecanemab-irmb) 100 mg/ml injection for intravenous (IV) use is indicated for the treatment of Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.



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