China's NMPA designates Eisai's Leqembi BLA for priority review

The Biologics License Application (BLA) for Leqembi (lecanemab), an investigational anti-amyloid beta (Aβ) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China, according to Japanese drugmaker Eisai (TYO: 4523), which is developing the Alzheimer’s disease agent with US biotech Biogen (Nasdaq: BIIB).

The Priority Review and Approval Procedure was implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this Procedure, the assessment period is expected to be shortened.

In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022. Eisai initially submitted a package that includes 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 (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed Aβ accumulation in the brain. Eisai will submit additional data including full data of the Clarity AD study, as directed by the NMPA.