HQ Team
September 25, 2023: Eisai Co., and Biogen Inc., announced that their drug to treat Alzheimer’s disease and cognitive impairment has been approved in Japan.
Leqembi, an intravenous infusion, slows the progression of mild cognitive impairment and mild dementia in Alzheimer’s.
The US Food and Drug Administration granted Leqembi accelerated approval on January 6, 2023, and traditional approval on July 6, 2023.
In Japan, an application for marketing approval was filed and was designated for priority review in January 2023. Japan is the second country to grant approval, after the US.
“We believe that we have turned a new page in the history of Alzheimer’s disease treatment,” Haruo Naito, Chief Executive Officer at Eisai said in a statement.
“Alzheimer’s disease is a progressive and serious disease that not only causes significant impairment and burden for the people living with it and their care partners but also has a tremendous impact on society as a whole,” he said.
Japan’s approval makes “it the first approved anti-amyloid Alzheimer’s disease treatment shown to reduce the rate of disease progression and to slow cognitive impairment in the early and mild dementia stages of the disease in Japan.”
EU, China, Canada
Eisai will conduct a post-marketing special use results survey in all patients who are administered Leqembi ― a condition for approval by the Ministry of Health, Labour and Welfare.
In Japan, Eisai and Biogen Japan will co-promote the drug, with Eisai distributing the product as the Marketing Authorization Holder.
Eisai will lead the drug’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having the final decision-making authority.
Eisai has also submitted applications for approval of lecanemab in the EU, China, Canada, Great Britain, Australia, Switzerland, South Korea and Israel.
In China and Israel, the applications have been designated for priority review, and in Great Britain, 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.
