Biogen Inc.‘s (NASDAQ:BIIB) partner Eisai Co., Ltd, on Friday filed a new drug application for Leqembi (lecanemab) seeking approval for a subcutaneous formulation (SC-AI) as a new route of administration to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
The application is based on data from multiple subcutaneous (SC) administration sub-studies of lecanemab conducted as part of the Phase 3 Clarity AD open-label extension (OLE), following the 18-month core study in individuals with Alzheimer‘s disease (AD) or mild stage of AD dementia.
Once-weekly administration of SC-AI 500mg resulted in equivalent exposure to once every two weeks intravenous (IV) administration and similar clinical and biomarker benefits.
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Subcutaneous administration demonstrated a safety profile similar to IV administration, with less than 2% incidence of systemic injection/infusion-related reactions.
If approved, the SC-AI of 500 mg (two 250 mg injections) could be used to administer a once-weekly dose at home from the initiation of treatment, as an alternative to the current IV administration every two weeks dose in the hospital setting.
The injection time for each autoinjector (250mg injection) is approximately 15 seconds. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as infusion preparation and nurse monitoring, while streamlining the overall AD treatment care pathway.
On Tuesday, the companies completed the rolling submission of the Supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) for Leqembi SC-AI.
BIIB Price Action: Biogen shares were down 0.24% at $181.50 at the time of publication on Friday. The stock is trading near its 52-week high of $185.17, according to Benzinga Pro data.
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