Mar 06, 2023 10:58 JST

Source: Eisai

FDA Accepts Eisai's Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBITM (lecanemab-irmb) for the Treatment of Alzheimer's Disease
- Confirmatory Phase 3 Clarity AD data to be evaluated by FDA in determining whether to convert accelerated approval of LEQEMBI to a traditional approval
- Priority Review accelerates FDA review time with a Prescription Drug User Fee Act (PDUFA) target action on July 6, 2023

TOKYO and CAMBRIDGE, Mass., Mar 06, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai's supplemental Biologics License Application (sBLA) for LEQEMBITM (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to a traditional approval. The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting.

LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibrils*) and insoluble forms of amyloid beta (Aβ), approved under the Accelerated Approval Pathway for the treatment of Alzheimer's Disease (AD) on January 6, 2023.

On the same day that LEQEMBI received its accelerated approval, Eisai submitted the sBLA to the FDA for approval under the traditional pathway.

The sBLA is based on the findings from Eisai's recently published large, global confirmatory Phase 3 clinical trial, Clarity AD. LEQEMBI met the primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, results of the Clarity AD study were presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine.

LEQEMBI was approved under accelerated approval in the U.S. and was launched in the U.S. on January 18, 2023. The accelerated approval was based on Phase 2 data that demonstrated that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD, and its continued approval may be contingent upon verification of LEQEMBI's clinical benefit in a confirmatory trial. The FDA has determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.

Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

Treatment with LEQEMBI should only be initiated in patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology.

* Protofibrils are large Aβ aggregated soluble species of 75-500 Kd.1 To learn more, visit www.LEQEMBI.com.

For more information, visit www.eisai.com/news/2023/pdf/enews202316pdf.pdf.

Source: Eisai
Sectors: BioTech

Copyright ©2025 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Related Press Release


Eisai Representative Corporate Officer and CEO Haruo Naito Awarded the Order of the Rising Sun, Gold and Silver Star
April 30 2025 13:17 JST
 
Leqembi (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer's Disease to be Authorized in the European Union
April 18 2025 15:52 JST
 
Eisai to Divest Rights for Pariet in China to Peak Pharma
April 01 2025 12:15 JST
 
World's First Early Alzheimer's Disease Treatment Developed in Japan LEQEMBI Receives Prime Minister's Award at the 12th Technology Management and Innovation Awards
March 25 2025 16:28 JST
 
Eisai Selected as a Nadeshiko Brand 2025 as a Listed Company Excelling in Promotion of Women in the Workplace
March 25 2025 11:21 JST
 
Eisai Recognized as "2025 Kenko Investment for Health" for the First Time and Certified as "Outstanding Organization Of Kenko Investment for Health Program (White 500)" for the Sixth Time
March 10 2025 19:24 JST
 
Eisai: Update on the Co-Promotion of the Oral Antifungal Agent Nailin Capsules 100mg in Japan
March 05 2025 08:09 JST
 
Eisai Receives Regulatory Review Outcome for Lecanemab as a Treatment for Early Alzheimer's Disease in Australia
March 04 2025 16:22 JST
 
"Fatigue Recovery While You Sleep!" Eisai to Launch Designated Quasi-Drug Drink "Chocola BB Nightwell"
March 03 2025 14:41 JST
 
The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease
March 03 2025 12:53 JST
 
More Press release >>

Latest Press Release


More Latest Release >>