Eisai Announces Filing Of New Drug Application For Leqembi In Japan

(RTTNews) - BioArctic AB's (BIOA-B.ST) partner Eisai (4523.T) announced that they have filed a new drug application for Leqembi or lecanemab for a subcutaneous formulation as a new route of administration to Japan's Pharmaceuticals and Medical Devices Agency. The application is based on data from multiple subcutaneous administration sub-studies of lecanemab conducted as part of the Phase 3 Clarity AD open-label extension, following the 18-month core study in individuals with Mild Cognitive Impairment due to Alzheimer's disease or mild stage of AD dementia.

Leqembi is the result of a collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic.

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