Pharma Focus Asia

FDA Accepts Application for Leqembi® (Lecanemab-IRMB) to Add IV Maintenance Dosing for Early Alzheimer's Disease Treatment

Monday, June 10, 2024

Eisai, BioArctic AB's partner, announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for less frequent monthly dosing of lecanemab-irmb (marketed as Leqembi in the U.S.). This application sets a Prescription Drug User Fee Act (PDUFA) action date for January 25, 2025. Leqembi is indicated for treating Alzheimer's disease (AD) in patients at the mild cognitive impairment or mild dementia stage.

The new monthly IV regimen aims to maintain effective drug concentrations for patients who have completed the initial biweekly IV phase, managing the clearance of toxic amyloid beta (Aβ) protofibrils. The sBLA is supported by data from Phase 2 and 3 studies, including the Clarity AD study and its extension.

Alzheimer's disease involves the accumulation of toxic amyloid proteins, necessitating ongoing treatment to manage disease progression. Extended use of Leqembi has shown benefits in removing these harmful protofibrils. If approved, this less frequent dosing schedule could offer a more convenient treatment option, potentially enhancing patient compliance.

Eisai has also initiated the rolling submission for a Biologics License Application (BLA) for a subcutaneous autoinjector form of Leqembi for weekly dosing, following its Fast Track designation by the FDA in May 2024.

Leqembi is approved in the U.S., Japan, China, and South Korea, with applications under review in several other regions including the EU, Australia, and Canada. Eisai oversees the clinical development, regulatory submissions, and commercialization of Leqembi, while BioArctic, which holds commercialization rights in the Nordic region, prepares for a joint launch pending European approval. BioArctic's involvement includes receiving milestone payments and royalties on global sales, without incurring development costs.

Lecanemab (Leqembi) is the result of a strategic alliance between BioArctic and Eisai, aimed at treating Alzheimer's disease by targeting both soluble and insoluble forms of amyloid-beta. Its approvals are based on comprehensive clinical studies that demonstrated significant efficacy in slowing disease progression.

BioArctic and Eisai have a longstanding collaboration dating back to 2005, focusing on Alzheimer's treatments. BioArctic's role includes commercialization rights in the Nordic region, contingent on regulatory approvals.



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