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).

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 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.

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

 
• By Jung Won Shin

Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.

Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
• By Vibha Ravi

Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?