1. Pink Sheet
  2. >>Geography
  3. >>Asia
  4. >>Japan

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 approval of a drug granted

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Japan

Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.

Japan Identifies Drugs ‘In Urgent Need’ Of Development

 
• By Lisa Takagi

Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.

Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By Lisa Takagi

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

Japan Expands Priority R&D List For Regular Vaccinations

 
• By Lisa Takagi

Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.

More from Asia

Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.

Japan Identifies Drugs ‘In Urgent Need’ Of Development

 
• By Lisa Takagi

Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.