Eisai has submitted a new drug application to Japan’s Pharmaceuticals and Medical Devices Agency for a subcutaneous autoinjector (SC-AI) form of Leqembi (lecanemab). SC-AI Leqembi is designed for the treatment of early Alzheimer’s disease (AD).
The application is based on results from various sub-studies of the drug, conducted as part of the phase 3 Clarity AD open-label extension and following an 18-month core study of individuals with early AD. The studies showed that once-weekly administration of SC-AI lecanemab gave equivalent drug exposure to the currently-approved administration route, biweekly intravenous (IV) dosing. SC-AI also demonstrated similar clinical and biomarker benefits, and a similar safety profile, to IV, with a less than 2% incidence of injection- or infusion-related reactions overall.
AD is a neurodegenerative disease caused by a continuous underlying neurotoxic process driven by protofibrils, beginning before amyloid plaque accumulation and continuing after plaque removal. Leqembi, a humanised immunoglobulin gamma (IgG1) monoclonal antibody, has the capability to fight AD in two ways, targeting both protofibrils and amyloid plaque.
If approved, SC-AI Leqembi could be used to treat early AD at home, as a weekly injection, which could help to reduce healthcare costs. Currently, LEQEMBI is approved in 51 countries and is under regulatory review in nine others. Eisai leads the development and regulatory submissions of Leqembi as part of its agreement with Biogen.
AloJapan.com