Eisai Seeks PMDA Approval for Subcutaneous Formulation of Alzheimer’s Drug Leqembi

Eisai has submitted an application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) seeking approval for a subcutaneous formulation of Leqembi (lecanemab). The proposed formulation would provide an alternative administration route for the drug, which is currently delivered intravenously. The application is supported by data collected from multiple subcutaneous administration sub-studies conducted as part of the Phase III Clarity trial.

The Phase III Clarity trial investigated the efficacy and safety of lecanemab in treating Alzheimer’s disease. Within this study, Eisai conducted several sub-studies focusing on subcutaneous delivery methods to evaluate their potential as a new option for patients. The findings from these studies form the basis of Eisai’s submission to PMDA, aiming to expand treatment options for individuals requiring this medication.

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