Neurocognitive Disorders

Lecanemab SC Formulation Under Review for Early Alzheimer Disease

Jaymin Kang, PharmD
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Publish Date
A Prescription Drug User Fee Act target date of August 31, 2025 has been set for the application.

The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for subcutaneous (SC) maintenance dosing of lecanemab-irmb for the treatment of Alzheimer disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease. 

Lecanemab, an amyloid beta-directed antibody, is currently approved for intravenous (IV) use under the brand name Leqembi® for the treatment of Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

The BLA for SC administration was based on data from the open-label extension of the phase 3 Clarity AD study (ClinicalTrials.gov Identifier: NCT03887455). The extension phase included 72 participants who received lecanemab for the first time as an SC injection, and 322 participants who previously received IV lecanemab in the core study period followed by the SC formulation in the extension study. 

Interim findings showed treatment with SC lecanemab resulted in 14% greater amyloid plaque removal in the brain at 6 months, assessed by amyloid positron emission tomography, compared with biweekly IV administration (centiloid reduction; -40.3 ± 2.27 vs -35.4 ± 1.14, respectively). Additionally, pharmacokinetics data showed 11% greater exposure, assessed by area under the curve, with the weekly SC formulation vs the biweekly IV formulation. 

With regard to safety, the rate of systemic injection reactions was found to be lower with SC administration compared with IV administration. The incidence of amyloid related imaging abnormalities with the SC formulation was comparable to the IV formulation. 

If approved by the FDA, patients who have completed the biweekly IV initiation phase with lecanemab, would be able to transition to the SC weekly maintenance regimen. The SC autoinjection process is expected to take 15 seconds and reduces the need for hospital or infusion site visits for maintenance administration.

A Prescription Drug User Fee Act target date of August 31, 2025 has been set for the application.

This article originally appeared on MPR

References:
  1. FDA accepts Leqembi® (lecanemab-irmb) Biologics License Application for subcutaneous maintenance dosing for the treatment of early Alzheimer’s disease. News release. Eisai. January 13, 2025. https://www.prnewswire.com/news-releases/fda-accepts-leqembi-lecanemab-irmb-biologics-license-application-for-subcutaneous-maintenance-dosing-for-the-treatment-of-early-alzheimers-disease-302349842.html.
  2. Eisai presents new Leqembi® (lecanemab-irmb) investigational subcutaneous formulation interim study results and clinical improvement data in earlier stages of early Alzheimer’s disease from additional analyses of Clarity AD at the Clinical Trials on Alzheimer’s Disease (CTAD) conference. News release. Eisai. October 26, 2023. https://www.eisai.com/news/2023/news202368.html.