Lecanemab Subcutaneous Formulation Approved for Maintenance in Early Alzheimer Disease

The Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Leqembi^® Iqlik^™, a once weekly lecanemab-irmb subcutaneous (SC) injection, for maintenance dosing to treat Alzheimer disease in patients with mild cognitive impairment or mild dementia stage of disease. 

Lecanemab is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta. Previously, it was only approved for administration as an intravenous (IV) infusion. 

The approval for maintenance dosing with the SC autoinjector was based on data from the open-label extension of the phase 3 CLARITY AD trial (ClinicalTrials.gov Identifier: NCT03887455). Findings showed that following completion of the 18-month biweekly IV initiation phase, transitioning to the SC injection at a dose of 360mg once weekly was found to maintain clinical and biomarker benefits (ie, reductions in amyloid beta plaque and plasma p-tau181 levels) similar to those observed with continued IV dosing.  

Among the 49 patients who received the SC maintenance dose, none experienced any local or systemic injection related adverse events. Additionally, the incidence of systemic reactions was lower with maintenance SC dosing vs maintenance IV dosing (<1% vs ~26%, respectively). Notably, amyloid-related imaging abnormalities rates were reported to be similar in the maintenance SC and IV groups. 

According to Eisai and Biogen, the new SC formulation is expected to reduce health care resources as well as allow patients the convenience of at-home administration.

Leqembi Iqlik is supplied as a 360mg/1.8mL single-dose prefilled autoinjector. The SC formulation is only approved as a maintenance dosing regimen, after 18 months of biweekly IV lecanemab 10mg/kg. 

The autoinjector is expected to be launched on October 6, 2025.

This article originally appeared on MPR