Lecanemab Accepted for US Review, Action Date Set for January: Eisai/Biogen

To read the full story

• Sign In
• Subscribe

Related Article

• Leqembi Likely to Face 15% Price Cut Under Special CEA Rule
  July 10, 2025

• Eisai CEO Anticipates Leqembi Approval in Europe and China by March
  December 18, 2023

• Leqembi to Cost 2.98 Million Yen per Year, Re-Pricing Might Be Triggered on Patient Upswing
  December 14, 2023

• Leqembi to Debut on Dec. 20; Eisai Sees SC Version and Blood Biomarker as Drivers for Wider Use
  December 14, 2023

• Leqembi OK’ed for Listing on Dec. 20; Peak Sales Put at 98.6 Billion Yen
  December 13, 2023

• Chuikyo Agrees to Adopt Normal Rules to Price, Re-Price Leqembi
  November 16, 2023

• Industry Prods Careful Debate on Creating Separate Rules for Leqembi Re-Pricing
  November 9, 2023

• Medical, Long-Term Care Data Linkage Holds Key to CEA: Leqembi Debate
  October 30, 2023

• Leqembi’s Initial Pricing Won’t Factor in Benefits in Long-Term Care
  October 19, 2023

• Post-Launch Re-Pricing Likely the Focus of Chuikyo Leqembi Discussions
  October 5, 2023

• As Chuikyo Begins Pricing Debate of Leqembi, Panelists Urge Safety, Fair Access
  September 28, 2023

• Leqembi Subject to Cost Control Rule for Potential Big Sellers, MHLW Still Set to Meet Listing Deadline
  September 26, 2023

• Japan Approves Eisai/Biogen’s Alzheimer’s Drug Leqembi
  September 25, 2023

• Eisai’s Alzheimer’s Drug Clears Advisory Panel, Now in Line for Japan Approval
  August 22, 2023

• Full US Nod in Hand, Eisai CEO Keeps 1 Trillion Yen Sales Target for FY2030
  July 10, 2023

• FDA Awards Full Approval to Eisai’s Alzheimer’s Drug
  July 7, 2023

• Eisai’s Leqembi Wins Coverage from US Veteran’s Body
  March 15, 2023

• FDA Accepts Eisai’s Lecanemab Application for Early July Target
  March 6, 2023

• Lecanemab Earns Priority Review in Japan, Eisai Aims for Approval by Year-End
  January 31, 2023

• Lecanemab Application Accepted for Review in Europe; FY2023 Approval Eyed
  January 30, 2023

• Alzheimer’s Drug Leqembi Now Available in US: Eisai/Biogen
  January 24, 2023

• Alzheimer’s Med Lecanemab Submitted in Japan: Eisai
  January 16, 2023

• Eisai Files Alzheimer’s Med Lecanemab in Europe
  January 12, 2023

• Leqembi Likely to Hit Peak Sales after 2030, US$26,500 Price Matches Value: Eisai CEO
  January 10, 2023

• Lecanemab Nabs Accelerated Approval in US, Set to Hit Market Late January
  January 10, 2023

• Eisai Says 2 Trial Deaths Not Attributed to Lecanemab, No Change in Submission Plan
  December 1, 2022

• Lecanemab Hits PIII Mark with 27% Cut in Clinical Decline, Eisai Set for Submissions by March-End
  September 29, 2022

• Eisai Completes Rolling Submission for Lecanemab in US
  May 11, 2022

• Lecanemab Scores Positive Results in PIIb Study: Eisai/Biogen
  March 23, 2022

• Eisai Begins Data Submission for Lecanemab for Swift Approval in Japan
  March 7, 2022

• Eisai’s Lecanemab Bags Fast-Track Status in US
  December 27, 2021

• Eisai/Biogen Begin US Rolling Submission for Alzheimer’s Med Lecanemab
  September 28, 2021

• BAN2401 Gets FDA’s Breakthrough Therapy Tag: Eisai/Biogen
  June 25, 2021