WESTON (dpa-AFX) - Eisai submitted to the U.S. Food and Drug Administration
a Supplemental Biologics License Application or sBLA for monthly lecanemab-irmb
(U.S. brand name: Leqembi) intravenous or IV maintenance dosing, Eisai Co., Ltd.
and Biogen Inc. (BIIB) said in a statement.

Leqembi is indicated for the treatment of Alzheimer's disease (AD) in patients
with mild cognitive impairment or mild dementia stage of disease --collectively
referred to as early Alzheimer's disease.

The sBLA is based on modeling of observed data from the Phase 2 study and its
open-label extension as well as Clarity AD study and its OLE study.

Eisai had aimed to submit a Biologics License Application (BLA) for weekly
maintenance therapy using subcutaneous (SC) administration in March 2024. To
respond to the FDA's recent requirement of additional three-month immunogenicity
data at the proposed maintenance dose of 360 mg weekly, Eisai planned to
initiate a rolling BLA for lecanemab SC maintenance in March 2024, under the
existing Fast Track and Breakthrough Therapy designations.

However, Eisai was recently informed by the FDA that a Fast Track designation
specific for the SC formulation is needed to receive rolling review. Following
the guidance, Eisai submitted a request for Fast Track designation for the SC
formulation and will initiate a rolling submission should the FDA grant this
designation. The Fast Track designation will be determined within 60 days from
the March 2024 submission.

Leqembi is now approved in the U.S., Japan and China, and applications have been
submitted for review in the European Union, Australia, Brazil, Canada, Hong
Kong, Great Britain, India, Israel, Russia, Saudi Arabia, South Korea, Taiwan,
Singapore, and Switzerland.

Eisai serves as the lead for lecanemab's development and regulatory submissions
globally with both companies co-commercializing and co-promoting the product and
Eisai having final decision-making authority.

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