English | 简体中文 | 繁體中文 | 한국어 | 日本語
Monday, 9 January 2023, 21:55 JST
Share:
    

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 9, 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.

Topic: Press release summary
Source: Eisai

Sectors: BioTech
https://www.acnnewswire.com
From the Asia Corporate News Network


Copyright © 2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.

 

Eisai Related News
Thursday, 28 November 2024, 16:26 JST
"LEQEMBI" (Lecanemab) for the Treatment of Alzheimer's Disease Launched in South Korea
Tuesday, 26 November 2024, 15:50 JST
Eisai Signs Research Collaboration Agreement with The National Center of Neurology and Psychiatry to Initiate Apolipoprotein E Genetic Testing in the "AD-DMT Registry" in Japan
Wednesday, 20 November 2024, 11:51 JST
Rozebalamin for Injection 25mg (Mecobalamin) for Amyotrophic Lateral Sclerosis Launched in Japan
Wednesday, 20 November 2024, 10:24 JST
Anticancer Agent "TASFYGO Tablets 35mg" (Tasurgratinib Succinate) Launches in Japan for Biliary Tract Cancer with FGFR2 Gene Fusion or Rearrangements
Friday, 15 November 2024, 17:33 JST
Nationwide TV Commercial Launched in Japan to Raise Awareness About MCI (Mild Cognitive Impairment)
More news >>
Copyright © 2024 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Cookies Policy | Privacy Policy | Disclaimer | Terms of Use | RSS
US: +1 214 890 4418 | China: +86 181 2376 3721 | Hong Kong: +852 8192 4922 | Singapore: +65 6549 7068 | Tokyo: +81 3 6859 8575