Biogen, Eisai say Leqembi BLA accepted in China

Eisai (ESALY) and Biogen (BIIB) announced that the Biologics License Application for the subcutaneous formulation of LEQEMBI, an anti-amyloid beta protofibril antibody, has been accepted by the National Medical Products Administration in China. If approved, the SC-AI of 500 mg could be used to administer a once-weekly dose at home from the initiation of treatment, as an alternative to the current IV administration in the hospital setting. The potential approval of SC-AI would expand the option for patients and care partners to receive LEQEMBI treatment at home. The injection time for each autoinjector is approximately 15 seconds. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as preparation for infusion and nurse monitoring, while streamlining the overall AD treatment care pathway.