Eisai Begins Rolling SBLA Submission For LEQEMBI IQLIK Subcutaneous Autoinjector

(RTTNews) - Eisai Co., Ltd. (ESALY.PK, ESALF.PK) and Biogen Inc. (BIIB) announced that Eisai has initiated the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for lecanemab-irmb (U.S. brand name: LEQEMBI) subcutaneous autoinjector (SC-AI), LEQEMBI IQLIK, as a weekly starting dose after the FDA granted Fast Track Status.

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

If approved by the FDA, the LEQEMBI IQLIK 500 mg subcutaneous (SC) dosing regimen—administered as two 250 mg injections—could offer a once-weekly starting dose alternative to the current bi-weekly intravenous (IV) administration. This advancement would expand treatment options for patients and care partners, enabling LEQEMBI therapy to be delivered at home from initiation through maintenance, with the flexibility to choose between IV and SC delivery methods.

The current injection time for each LEQEMBI IQLIK autoinjector takes approximately 15 seconds. The SC formulation also has the potential to reduce healthcare resources associated with IV maintenance dosing, such as preparation for infusion and nurse monitoring, while streamlining the overall AD treatment pathway.

LEQEMBI is currently approved in 48 countries and is under regulatory review in 10 countries.

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

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