Biogen Says BLA For Lecanemab Gets Priority Review By NMPA In China

(RTTNews) - Eisai Co., Ltd. and Biogen Inc. (BIIB) Tuesday said the Biologics License Application (BLA) for lecanemab, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.

Lecanemab is an investigational anti-amyloid beta (Aß) protofibril antibody for the treatment of patients with early Alzheimer disease.

In January this year, the FDA had granted accelerated approval for lecanemab, marketed as LEQEMBI in the U.S, to treat patients with mild cognitive impairment or mild dementia due to Alzheimer disease.

A marketing authorization application (MAA) to the European Medicines Agency (EMA) was also submitted in January.