Lecanemab (Leqembi) has just been approved in Japan (25 September) by the ministry of health, labour (MHLW)and welfare for the treatment of Alzheimer’s Disease (AD) as a disease modifying therapy. The drug which was co-developed by Eisai and Biogen was approved in the US in May 2023. It is currently under review by the European Medicine Agency.
Leqembi works by selectively binding to and eliminating the most toxic Aβ aggregates (protofibrils) that contribute to neurotoxicity in AD. It has been shown in the global phase 3 trial that the drug slowed cognitive decline by 27% vs placebo over 18 months period.
AD is a disease that affects over 55 million people worldwide and the incidence of AD in Japan is one of the highest in the world. There is a lot of excitement about the prospect of this drug to meet the medical needs of at least a proportion of AD patients ( those in the early stage of the disease).
The next important step is the decision on pricing by MHLW. With the increasing pressure on governments worldwide to lower drug prices, tough negotiations are expected between the sponsors and MHLW.
