|
| Tuesday, 28 September 2021, 10:37 HKT/SGT | |
| |  | |
Source: Eisai | |
|
|
|
|
| Lecanemab is an Anti-Amyloid Beta (Abeta) Protofibril Antibody |
TOKYO, Sept 28, 2021 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. today announced that Eisai has initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab (BAN2401), the company's investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer's disease (early AD). The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial (Study 201) in people with early AD and confirmed amyloid pathology. The lecanemab Phase 2b trial results demonstrated a high degree of Abeta plaque lowering and consistent reduction of clinical decline across several clinical endpoints. The correlation between the extent of Abeta plaque reduction and effect on clinical endpoints in Study 201 further supports Abeta as a surrogate endpoint that is reasonably likely to predict clinical benefit. AD is a serious, progressive and devastating disease with few treatment options. Eisai is utilizing the accelerated approval pathway after discussion with the FDA and aims to bring a new treatment option to people living with early AD, their families and healthcare professionals.
In June, 2021, lecanemab was granted Breakthrough Therapy designation, which is an FDA program intended to expedite the development and review of medicines for serious or life threatening conditions. Eisai has an agreement with the FDA to submit the BLA for lecanemab as a rolling submission. This agreement allows completed portions of the application to be submitted to the FDA for review on an ongoing basis. After all portions are submitted to the FDA and the agency accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set.
The BLA submission for lecanemab is primarily based on the results of the proof-of-concept Study 201 in 856 patients with mild cognitive impairment (MCI) due to AD and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology. The results were published in a peer-reviewed journal in April 2021.1 Study 201 explored the impact of treatment with lecanemab on reducing brain Abeta and clinical decline. At 18 months of treatment, 10 mg/kg biweekly lecanemab reduced brain amyloid by 0.306 SUVr units (from a baseline mean of 1.37), and over 80% of subjects became amyloid negative by visual read. Furthermore, the extent of reduction in amyloid was correlated with slower clinical decline on ADCOMS (Alzheimer's Disease Composite Score), CDR-SB (Clinical Dementia Rating-Sum-of-Boxes), and ADAS-cog (Alzheimer Disease Assessment Scale-Cognitive Subscale) at the treatment group and patient level. The rate of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an adverse event associated with amyloid targeted therapies, for the 10 mg/kg biweekly dosing was 9.9%.
After completion of the Core period and a Gap period off treatment (average of 24 months), all 180 patients in the Study 201 open-label extension study received 10 mg/kg biweekly lecanemab dosing. The data confirmed lecanemab produces reductions of amyloid PET SUVr, with significant reduction occurring as early as 3 months, and >80% of subjects achieved amyloid negative status by visual read in as early as 12 months [https://www.eisai.co.jp/ir/library/presentations/pdf/e4523_210730.pdf]. Significant amyloid reduction relative to placebo in those exposed to lecanemab in the Core period was maintained while off-treatment over the Gap period. The rate of ARIA-E was consistent with the Core study at around 10%.
The lecanemab Clarity AD Phase 3 clinical trial in early AD is ongoing and completed enrollment in March 2021 with 1,795 patients. The U.S. FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Blinded safety data from Clarity AD will be included to support the BLA.
"With the worldwide population growing and aging, the number of people living with AD is on the rise. AD imposes an enormous burden on not only people living with AD and their families but also for society. We recognize the strong and urgent expectations from stakeholders to further advance a treatment system for this disease. For many years, Eisai has endeavored to understand the anxieties of people living with AD and has been conducting research and development of novel therapies," said Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. "The lecanemab rolling BLA submission marks a new milestone toward the advancement of a treatment system for AD. As part of our human health care mission, we are committed to bringing new medicines to people living with AD and their families as early as possible."
"The Alzheimer's community welcomes scientific innovation that creates more treatment options for people living with this terrible neurodegenerative disease," said Jeffrey Cummings, M.D., ScD, lecanemab manuscript author and director at the Chambers-Grundy Center for Transformative Neuroscience, University of Nevada Las Vegas. "Based on the efficacy and safety results of the Phase 2b study and preliminary results from the open-label extension study, I am optimistic about the potential lecanemab may have as a treatment choice for patients with early Alzheimer's to ameliorate the otherwise inevitable decline they face."
"It is our vision that patients and their families have choice and access to multiple treatment options for Alzheimer's disease. The rolling submission of lecanemab for FDA review under the accelerated pathway is a positive step toward that goal," said Michel Vounatsos, Chief Executive Officer at Biogen. "We believe that treatments directed at amyloid beta reduction in the brain have the potential to transform diagnosis and treatment of Alzheimer's disease. We look forward to continuing to work with Eisai to pioneer science, advance knowledge, and serve the needs of Alzheimer's patients."
MEDIA CONTACT:
Eisai Co., Ltd.
Public Relations Department
TEL: +81-(0)3-3817-5120
Eisai Inc. (U.S.)
Libby Holman
+1-201-753-1945
Libby_Holman@eisai.com
INVESTOR CONTACT:
Eisai Co., Ltd.
Investor Relations Department
TEL: +81-(0)70-8688-9685
MEDIA CONTACT:
Biogen Inc.
Allison Parks
+1-781-464-3260
public.affairs@biogen.com
INVESTOR CONTACT:
Biogen Inc.
Mike Hencke
+1-781-464-2442
IR@biogen.com
For more information, visit https://www.eisai.com/news/2021/pdf/enews202177pdf.pdf.
Topic: Press release summary
Source: Eisai
Sectors: BioTech
http://www.acnnewswire.com
From the Asia Corporate News Network
Copyright © 2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
|
|
|
|
|
|
| Eisai |
| Nov 26, 2024 14:50 HKT/SGT |
|
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 |
| Nov 20, 2024 10:51 HKT/SGT |
|
Rozebalamin for Injection 25mg (Mecobalamin) for Amyotrophic Lateral Sclerosis Launched in Japan |
| Nov 20, 2024 09:24 HKT/SGT |
|
Anticancer Agent "TASFYGO Tablets 35mg" (Tasurgratinib Succinate) Launches in Japan for Biliary Tract Cancer with FGFR2 Gene Fusion or Rearrangements |
| Nov 15, 2024 16:33 HKT/SGT |
|
Nationwide TV Commercial Launched in Japan to Raise Awareness About MCI (Mild Cognitive Impairment) |
| Nov 15, 2024 13:31 HKT/SGT |
|
Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer's Disease |
| Nov 5, 2024 10:35 HKT/SGT |
|
Eisai's Corporate Venture Capital Subsidiary, Eisai Innovation, Inc., Selected for AMED's 'Strengthening Program for Pharmaceutical Startup Ecosystem" |
| Nov 1, 2024 12:56 HKT/SGT |
|
Eisai Completes Rolling Submission to US FDA for LEQEMBI(R) (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease Under the Fast Track Status |
| Oct 31, 2024 12:56 HKT/SGT |
|
Eisai Presents Data on Benefits of Long-Term Administration of Dual-Acting Lecanemab at the 17th Clinical Trials for Alzheimer's Disease (CTAD) Conference |
| Oct 31, 2024 10:33 HKT/SGT |
|
Eisai Presents Latest Clinical Findings Suggesting Inhibition of Tau Propagation by Anti-MTBR Tau Antibody E2814 at the 17th Clinical Trials on Alzheimer's Disease Conference (CTAD) |
| Oct 17, 2024 19:01 HKT/SGT |
|
A Joint Regional Cohort Study by Shimadzu, Eisai, Oita University, and Usuki City Medical Association |
| More news >> |
 |
|
|
|
