Eisai has received regulatory approval in Japan for a subcutaneous autoinjector formulation of Leqembi, marketed as Leqembi Pen, for the treatment of early Alzheimer’s disease.
The product enables patients or care partners to self-administer two injections totaling 500 mg once weekly, permitting at-home dosing that complements the existing intravenous regimen administered every two weeks.
The approval was based on integrated results and modeling from the 18-month core Phase 3 Clarity AD study and multiple subcutaneous sub-studies in the long-term extension, and the company claims once-weekly subcutaneous administration showed similar exposure to the intravenous regimen and is expected to provide comparable efficacy.
The company reports that the overall safety profile for subcutaneous administration was generally similar to intravenous use, with systemic injection- or infusion-related reactions observed less frequently with the subcutaneous route (1.4%).
At-home self-administration will be possible after listing in the injectable drug list designated by the Minister of Health, Labour and Welfare and deliberation by the Central Social Insurance Medical Council, with initial doses administered or supervised by a physician and education required for patients and caregivers.
