Eisai and Biogen have filed a new drug application for “LEQEMBI®” in Japan seeking approval for a subcutaneous formulation, which showed equivalent exposure and clinical benefits compared to intravenous administration. If approved, the once-weekly dose could be administered at home, reducing healthcare resources associated with IV dosing. Only LEQEMBI targets both protofibrils and amyloid plaque in Alzheimer’s disease, impacting tau downstream. Eisai leads lecanemab’s development globally, with Biogen co-commercializing the product. AD is a progressive disease with hallmarks of amyloid beta and tau, caused by protofibrils. LEQEMBI is currently approved in 51 countries and regions and is under regulatory review in 9 countries.

Read more at GlobeNewswire: Eisai Submits New Drug Application for Subcutaneous