FDA Accepts Eisai, BioArctic's Leqembi IV Maintenance sBLA

Eisai and BioArctic have announced that the FDA has accepted their supplemental Biologics License Application (sBLA) for a monthly intravenous (IV) maintenance dosing of their Alzheimer's disease treatment, Leqembi. The new dosage plan targets patients who have already completed the biweekly IV initiation phase. Its primary goal is to maintain effective drug levels to clear amyloid beta protofibrils, which are toxic and cause neuronal damage.

The sBLA is backed by data from various studies, including the phase 2 Study 201 and its extension, as well as the Clarity AD study. These studies underline the necessity for continuous treatment in Alzheimer’s disease, given its progressive nature. Findings show that using Leqembi beyond 18 months prolongs its benefits by constantly removing harmful protofibrils. Should it gain approval, this monthly dosing regimen will offer a less burdensome option for the long-term treatment of the disease.

Leqembi is already approved for use in the United States, Japan, China, and South Korea. Applications are currently under review in several other countries, including those within the European Union and other regions. The FDA has set a decision date of January 25, 2025, to rule on the sBLA.

In March, Eisai planned to submit a rolling BLA for a weekly subcutaneous maintenance dose of Leqembi. However, the FDA informed them that additional immunogenicity data and a Fast Track designation for this subcutaneous formulation were required. Eisai received the Fast Track designation in May and has since begun the rolling submission of the BLA for subcutaneous maintenance dosing.

Eisai is at the forefront of the development, approval, and commercialization of lecanemab for Alzheimer’s disease. BioArctic, meanwhile, will handle its commercialization in the Nordic region, pending European approval.