LEQEMBI IQLIK accepted as a SBLA as a subcutaneous starting dose for the treatment of early alzheimer’s disease under priority review

Biogen has recently announced that the U.S. FDA has accepted for review Eisai’s Supplemental Biologics License Application for lecanemab-irmb subcutaneous autoinjector, LEQEMBI IQLIK, as a weekly starting dose. LEQEMBI is indicated for the treatment of Alzheimer’s disease in patients with Mild Cognitive Impairment or mild dementia stage of disease.

If the FDA approve LEQEMBI IQLIK 500 mg SC dosing regimen, the autoinjector could be used to administer a once-weekly starting dose, as an alternative to the current bi-weekly intravenous dosing. This would enable patients and care partners to choose SC administration at home for both treatment initiation and the currently approved maintenance therapy offering the option of SC or IV administration throughout the entire treatment journey.

Note that the sBLA is supported by data evaluating SC administration of lecanemab across a range of doses and as part of sub-studies within the Phase 3 Clarity AD open-label extension following the 18-month core study in individuals with early AD. Data show that once-weekly administration of the 500 mg of SC-AI achieved equivalent exposure to once every two weeks IV administration and similar clinical and biomarker benefits. SC administration demonstrated a safety profile similar to IV administration, with less than 2% incidence of systemic injection or infusion-related reactions.

In addition, LEQEMBI is currently approved in 53 countries and regions and is under regulatory review in 7 countries. In August 2025, the US FDA approved LEQEMBI IQLIK 360 mg for weekly subcutaneous maintenance dosing after 18 months of IV treatment every two weeks.

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Related Topics and Keywords

Alzheimer's disease, biogen, leqembi, priority review