HQ Team
January 16, 2023: Eiasi Co., a Japanese pharmaceutical company, has submitted a marketing authorization application for a drug, lacanemab, to treat Alzheimer’s disease.
The drug, also known as leqembi in the US, additionally treats mild dementia. According to a company statement, the company applied to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
The PMDA is an Independent administrative institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan.
The Ease application is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in the early stages of Alzheimer’s.
Shorten review period
Before submitting this application, Eisai utilized the prior assessment consultation system of PMDA, aiming to shorten the review period for lecanemab.
In the US, lecanemab was granted accelerated approval as a treatment for Alzheimer’s disease by the US Food and Drug Administration (FDA) on January 6, 2023.
On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.
Eisai submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023.
In China, Eisai submitted data for BLA to the National Medical Products Administration (NMPA) of China in December 2022.
. Before submitting this application, Eisai utilized the prior assessment, consultation system of PMDA, aiming to shorten the review period for lecanemab.
Eisai serves as the lead on lecanemab development and regulatory submissions globally, with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai has final decision-making authority.
