Eisai (ESAIY) and Biogen (BIIB) announced that Eisai has filed a new drug application for Leqembi seeking approval for a subcutaneous formulation as a new route of administration to Japan’s Pharmaceuticals and Medical Devices Agency. “If approved, lecanemab would be the first and only anti-amyloid treatment in Japan to offer an at-home injection from the initiation of treatment for this progressive, relentless disease,” the companies stated. Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
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