Eisai Co and Biogen’s lecanemab designated for Priority Review by NMPA

Eisai and Biogen announced that its BLA for LEQEMBI™ (in the US) (lecanemab) an investigational anti-amyloid beta (Aβ) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.  The assessment period for LEQEMBI™ is therefore expected to be shortened.  The NMPA reviewed data from the phase II clinical trial (Study 201) and the top-line data of the large global Phase III Clarity AD study in mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD with confirmed Aβ accumulation in the brain.