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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...

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Welireg Among Japan Recommendations; Economic Policy Raises Hopes Of Higher Prices

 
• By Lisa Takagi

Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.

Citeline Japan Awards 2025 - Enter Now!

 
• By Ian Haydock and Lisa Takagi

The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get your submissions in by this date. Sponsorship opportunities and tables for the event are also available.

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By Lisa Takagi

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.

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.

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