Jan 09, 2023 21:55 JST

Source: Eisai

Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer's Disease
Submission for traditional approval follows FDA accelerated approval of LEQEMBI on the same day, and is based on data from the confirmatory Phase 3 Clarity AD clinical trial

TOKYO, Jan 09, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced Eisai has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) supporting the conversion of the Accelerated Approval of LEQEMBI (lecanemab-irmb) 100 mg/mL injection for intravenous use to a traditional approval. This sBLA is subject to validation of whether the FDA accepts the application for review. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble ("protofibrils")* and insoluble forms of amyloid beta (Abeta), approved under Accelerated Approval Pathway by the FDA on January 6, 2023, for the treatment of Alzheimer's Disease (AD). 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.

Accelerated Approval of LEQEMBI was based on Phase 2 data that demonstrated LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD. Continued approval for this indication is contingent upon verification of LEQEMBI's clinical benefit in a confirmatory trial. The sBLA for LEQEMBI is based on the data from the Phase 3 confirmatory Clarity AD clinical trial. In Clarity AD, LEQEMBI met the primary endpoint and all key secondary endpoints with highly statistically significant results, and the profile of Amyloid-Related Imaging Abnormalities (ARIA) incidence was within expectations. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, peer-reviewed medical journals.

"We deeply appreciate the cooperation of people living with Alzheimer's disease and healthcare professionals who participated in LEQEMBI's Phase 3 Clarity AD clinical study, which enabled us to submit this sBLA. Alzheimer's disease causes significant impairment and burden to both the people living with this disease and their families, as well as having a profound impact on society," said Haruo Naito, Chief Executive Officer at Eisai. "The fact that Eisai was able to file LEQEMBI's supplemental Biologics License Application for traditional FDA approval on the same day we received accelerated approval demonstrates our commitment to the Alzheimer's disease community and is a major step forward in ensuring access for all those in the U.S living with this disease in need of this medicine. We will continue to actively cooperate with the FDA's review."

Eisai has initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022. Eisai plans to file for marketing authorization applications of lecanemab in Japan and EU by the end of Eisai's FY2022, which ends March 31, 2023.

"Today's filing is an important milestone for people living with Alzheimer's disease, demonstrating the resilience of the scientific and medical communities in their fight against this terrible disease despite the many setbacks and the challenges they've faced," said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen. "We commend Eisai for their leadership on the development of lecanemab and for the speed in which they were able to complete this filing, which is based on important new data from the pivotal late-stage Clarity AD study."

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.

* Protofibrils are large Abeta aggregated soluble species of 75-500 Kd. 1, 2
To learn more, visit www.LEQEMBI.com.

For more information, visit www.eisai.com/news/2023/pdf/enews202304pdf.pdf.

Source: Eisai
Sectors: BioTech

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

Related Press Release


Eisai to Launch "Pariet S," the First Proton Pump Inhibitor RX-to-OTC in Japan
June 02 2025 16:46 JST
 
New Drug Approval for In-House Developed Anti-Insomnia Drug DAYVIGO (Lemborexant) in China
May 28 2025 16:45 JST
 
Eisai Demonstrates Commitment to Oncology Innovation at ASCO 2025
May 21 2025 14:00 JST
 
Eisai Satisfies All-Case Surveillance Requirement for Anticancer Agent Remitoro
May 16 2025 16:21 JST
 
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
 
More Press release >>

Latest Press Release


More Latest Release >>