WESTON (dpa-AFX) - Eisai Co., Ltd. and Biogen Inc. (BIIB) said that Eisai
has initiated the rolling submission of a Biologics License Application or BLA
to the U.S. Food and Drug Administration or FDA for lecanemab-irmb (U.S. brand
name: LEQEMBI) subcutaneous autoinjector for weekly maintenance dosing after it
was granted Fast Track designation by the FDA.

LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients
with Mild Cognitive Impairment (MCI) or mild dementia stage of disease.

If approved by the FDA, the LEQEMBI autoinjector could be used to administer
LEQEMBI at home or at medical facilities. The injection process requires less
time than the IV formulation, the companies said.

As part of the subcutaneous autoinjector 360 mg weekly maintenance regimen under
review, patients who have completed the biweekly IV initiation phase would
receive weekly doses that maintain effective drug concentrations to sustain the
clearance of highly toxic protofibrils which can continue to cause neuronal
injury even after the amyloid-beta plaque has been cleared from the brain.

The companies noted that 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 submitted to the FDA a Supplemental Biologics License Application (sBLA)
for monthly LEQEMBI intravenous (IV) maintenance dosing in March 2024.

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