On 4 March, Eisai announced the initiation of a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data under the prior assessment consultation system in Japan for lecanemab (BAN2401), an investigational antibody targeting amyloid beta, for the treatment of Alzheimer's disease (AD). Based on discussions with the Ministry of Health, Labour and Welfare and PMDA, Eisai applied to PMDA with the aim of shortening the review period of lecanemab. This process is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data. The agency approved Eisai's request and Eisai has submitted the non-clinical lecanemab data to PMDA. The additional data of the application package will be submitted hereafter.
The lecanemab Clarity AD Phase III clinical study for mild cognitive impairment due to AD and mild AD is ongoing. Eisai plans to obtain the primary endpoint data from Clarity AD study in the fall of 2022, and based on the results of the study, aims to file for the manufacturing and marketing approval in Japan before end of March 2023. In September 2021, Eisai initiated a rolling submission to the US Food and Drug Administration (FDA) of a Biologics License Application for lecanemab, an investigational agent under the Accelerated Approval pathway for the treatment of early AD with confirmed amyloid pathology, and expects to complete this rolling submission in the second quarter 2022. Based on the results of the confirmatory Clarity AD study, Eisai plans to submit lecanemab for full approval to the US FDA before end of March 2023.