FDA accepts Eisai, BioArctic Leqembi IV maintenance sBLA

June 10, 2024

Eisai and BioArctic announced that FDA has accepted the partners' supplemental BLA for monthly intravenous (IV) maintenance dosing of approved Alzheimer's disease treatment, Leqembi. 

The new dosing regimen, intended for patients who have completed the biweekly IV initiation phase, aims to maintain effective drug levels to clear toxic amyloid beta protofibrils that cause neuronal damage. This sBLA is supported by data from several studies, including the phase 2 Study 201 and its extension, and the Clarity AD study.

Alzheimer's disease requires sustained treatment due to its progressive nature. Data indicate that continued use of Leqembi beyond 18 months prolongs benefits by continuously removing harmful protofibrils. If approved, the monthly dosing regimen will offer a less burdensome option for long-term treatment.

Leqembi is already approved in the U.S., Japan, China, and South Korea, with applications under review in several other countries, including those in the European Union and other regions. The FDA has set a decision date for January 25, 2025 for the sBLA.

Eisai had planned to submit a rolling BLA for a weekly subcutaneous maintenance dose of Leqembi back in March, but was informed by the FDA that additional immunogenicity data and a Fast Track designation for the SC formulation was required. The company received the Fast Track designation in May, and has now started the rolling submission of a BLA for a subcutaneous maintenance dosing.

Eisai leads the development, approval, and commercialization of lecanemab for Alzheimer's disease, while BioArctic will commercialize it in the Nordic region pending European approval.