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Japan Committee Recommends Lecanemab Approval

 
• By Lisa Takagi

An advisory committee of Japan’s MHLW has given a favorable opinion for the approval of Eisai's Alzheimer's drug lecanemab, setting the stage for a possible full official approval in September, after which it would be co-commercialized with global partner Biogen.

Japan’s AD population has grown over years. Lecanemab was granted Priority Review in January.
Japan’s AD population has grown over recent years • Source: Shutterstock

An advisory committee to Japan’s Ministry of Health, Labour and Welfare (MHLW) has agreed on a positive approval recommendation for Eisai Co., Ltd./Biogen, Inc.’s Leqembi (lecanemab), for the treatment of early Alzheimer’s disease (AD).

Although the amyloid beta-targeting antibody – the first in its class in Japan – still requires a formal final official approval from the ministry, once the committee decides to support...

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More from Japan

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.

Japan Reimburses 11 New Drugs But Slashes Price Of Others By Up To 20%

 
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US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

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