Biogen Inc. and partner Eisai Co. completed a rolling submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration on November 25, 2025 for the subcutaneous autoinjector LEQEMBI IQLIK, a weekly starting dose of lecanemab.
The sBLA proposes a 500 mg weekly subcutaneous dose that is designed to deliver exposure equivalent to the current 10 mg/kg bi‑weekly intravenous regimen. The application is supported by data from the Phase 3 Clarity AD open‑label extension, which demonstrated comparable safety and biomarker benefits with the subcutaneous route, and it follows the FDA’s Fast Track designation for the product.
LEQEMBI IQLIK had already received FDA approval in August 2025 for a 360 mg weekly subcutaneous maintenance dose after 18 months of intravenous treatment. The new submission would allow patients to begin therapy at home rather than requiring an initial IV induction course, potentially improving adherence and reducing clinic‑center visits. The autoinjector delivers the dose in approximately 15 seconds per injection.
If approved, the weekly subcutaneous formulation could expand access to the drug, lower health‑system resource use, and accelerate sales growth. Analysts expect the at‑home option to be a key driver for market penetration, especially as patients and caregivers seek more convenient treatment pathways. The move also strengthens LEQEMBI’s competitive position against rivals such as Eli Lilly’s donanemab by offering a more patient‑centric administration method.
Management emphasized the strategic importance of the new dosing option. “LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti‑amyloid treatment to offer at‑home injection from the start of therapy to help patients and care partners treat this progressive, relentless disease,” said a Biogen spokesperson. The company noted that the FDA will set a PDUFA action date upon acceptance of the sBLA.
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