HQ Team
December 13, 2023: Japan’s Eisai Co., and US-based Biogen Inc., announced its Leqembi injection will be sold in Japan from Japan from December 20, the second country after the US.
Leqembi got manufacturing and marketing approval for treating mild cognitive impairment and mild dementia due to Alzheimer’s disease in Japan on September 25, 2023.
The drug, which is meant to slow progression of the Alzheimer’s disease in its early stages, was included in the price listing on the Japan National Health Insurance Drug Price List on December 13, according to an Eisai statement.
“The product’s Optimal Clinical Use Guidelines were agreed at a general meeting of the Central Social Insurance Medical Council, an advisory body of the Japanese Ministry of Health, Labour and Welfare.”
In Japan, Eisai and Biogen will co-promote the drug, with Eisai distributing the product as the Marketing Authorization Holder.
Post-marketing survey
Eisai will conduct a post-marketing special use results survey on all patients who are administered Leqembi (all-case surveillance) until data from a certain number of patients are accumulated, in accordance with an approval condition imposed by the Ministry of Health.
The correct use of Leqembi will be promoted under the package insert and the Optimal Clinical Use Guidelines.
Training materials will be provided for healthcare professionals to assist in the management and monitoring of amyloid-related imaging abnormalities.
The U.S. Food and Drug Administration granted traditional approval on July 6, 2023. Eisai has also submitted applications for approval of lecanemab in 12 countries and regions, including EU and China.
Reduce time to market
In China and Israel, the applications have been designated for priority review, and in the UK, lecanemab has been designated for the Innovative Licensing and Access Pathway (ILAP), which aims to reduce the time to market for innovative medicines.
Eisai and Biogen have been collaborating on the joint development and commercialisation of Alzheimer’s Disease treatments since 2014.
Eisai serves as the lead of Leqembi development and regulatory submissions globally with both companies co-commercialising and co-promoting the product and Eisai having final decision-making authority.
