Eisai And Biogen Begin Rolling FDA Submission For LEQEMBI IQLIK Subcutaneous Autoinjector

Eisai Co., Ltd. (Tokyo, Japan) and Biogen Inc. announced that Eisai has initiated the rolling submission of a Supplemental Biologics License Application (sBLA) to the U.S. FDA for LEQEMBI® (lecanemab-irmb) subcutaneous autoinjector (SC-AI), branded as LEQEMBI IQLIK. The submission follows the FDA’s Fast Track designation and seeks approval for a once-weekly 500 mg SC dosing regimen as an alternative to the currently approved bi-weekly intravenous (IV) dosing. LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia, collectively referred to as early AD.

The sBLA is supported by data from the Phase 3 Clarity AD open-label extension (OLE) and sub-studies evaluating subcutaneous administration across a range of doses. If approved, the LEQEMBI IQLIK autoinjector would allow patients and caregivers to initiate and maintain therapy at home with weekly injections, offering a more convenient option compared to infusion center visits. Each injection is delivered in about 15 seconds. Beyond patient convenience, the SC formulation could help reduce healthcare resource use, such as infusion preparation and nurse monitoring, thereby streamlining the overall AD treatment pathway.

LEQEMBI is currently approved in 48 countries and under regulatory review in 10 more. Eisai leads global development and regulatory submissions for lecanemab, with Eisai and Biogen co-commercializing and co-promoting the product. Notably, LEQEMBI is the only Alzheimer’s therapy that targets both amyloid plaque and toxic protofibrils, which are believed to play a key role in cognitive decline by damaging neurons and promoting tau pathology.