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Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALY) began submission of application data in Japan aimed at getting an early approval of their Alzheimer's disease (AD) therapy lecanemab.
Eisai began a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data under the prior assessment consultation system in Japan for the investigational anti-amyloid beta antibody lecanemab (BAN2401).
The PMDA's process, known as 'prior assessment consultation' is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data.
Based on discussions with Japan's Ministry of Health, Labour and Welfare (MHLW) and PMDA, Eisai applied to PMDA to utilize the 'prior assessment consultation' process for lecanemab with the aim of shortening the review period.
The companies said the lecanemab Clarity AD Phase 3 clinical study for mild cognitive impairment due to AD and mild AD is ongoing.
Eisai expects to get main goal data from the Clarity AD trial in the fall of 2022, and based on the results aims to file for approval in Japan during Eisai's fiscal year 2022.
In September 2021, the companies began a rolling submission of an application for lecanemab for early AD.