EISAI COMPLETES ROLLING SUBMISSION TO THE U.S. FDA FOR BIOLOGICS LICENSE APPLICATION OF LECANEMAB FOR EARLY ALZHEIMER'S DISEASE UNDER THE ACCELERATED APPROVAL PATHWAY
TOKYO and CAMBRIDGE, Mass., May 9, 2022 /PRNewswire/ -- Eisai Inc. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today that Eisai has completed the rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) under the accelerated approval pathway for the investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (BAN2401) for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. As part of the completed rolling submission, Eisai has requested Priority Review. If the FDA accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set. While Eisai is currently submitting lecanemab under the accelerated approval pathway, the lecanemab Phase 3 confirmatory Clarity AD clinical trial conducted with 1,795 patients will report out in the Fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Dependent upon the results of the Clarity AD clinical trial, Eisai may submit for full approval of lecanemab to the FDA during fiscal year 2022.
The BLA submission for lecanemab is based on clinical, biomarker and safety data from the proof-of-concept Phase 2b (Study 201 Core) in 856 people with early AD with confirmed presence of amyloid pathology, biomarker and safety data from the Study 201 OLE (open-label extension study, 180 subjects), and blinded safety data from the confirmatory Clarity AD Phase 3 study (1,795 subjects). The large number of participants across these studies provides the FDA with extensive safety data. Study 201 explored the impact of treatment with lecanemab on reducing amyloid plaque and clinical decline. At 18 months of treatment, 10 mg/kg biweekly lecanemab reduced brain amyloid by a mean of 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. In the Core study, the overall rate of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an adverse event associated with anti-amyloid beta antibodies therapies was 9.9% (16/161) of patients treated with lecanemab 10 mg/kg biweekly compared with 0.8% (2/245) of placebo patients. The results from Study 201 were published in a peer-reviewed journal Alzheimer's Research and Therapy in April 2021.
"We would like to thank the people living with early AD and the healthcare professionals who participated in the lecanemab 201 study for their cooperation allowing completion of this BLA to the U.S. FDA. Alzheimer's disease is a progressive and devastating disease with few treatment options," said Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. "Eisai employees have spent time with people living with Alzheimer's disease and their families to truly understand their feelings and challenges and have been working to create new treatments for many years. Our comprehensive medicine creation approach along the Alzheimer's disease continuum reflects Eisai's long-term commitment to providing innovative treatments to the people living with AD, their families and healthcare professionals who urgently need new treatment options."
"With Alzheimer's disease, patients and their loved ones don't have the luxury of time. There is an enormous unmet need in this space, and we continue to make progress in advancing additional treatment options for people living with this devastating disease," said Michel Vounatsos, Chief Executive Officer at Biogen. "Anti-amyloid antibodies are a new wave of important medicines, which could provide patients and their physicians more options in addressing this complex disease."
Lecanemab was granted Breakthrough Therapy and Fast Track designations by the FDA in June and December 2021, respectively. In March 2022, Eisai initiated submission of application data to the Pharmaceuticals and Medical Devices Agency (PMDA) under the prior assessment consultation system in Japan with the aim of obtaining early approval for lecanemab, and aims to file for the manufacturing and marketing approval based on the results of Clarity AD during Eisai's fiscal year 2022.
Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
[Notes to editors]
1. About Lecanemab (BAN2401)
Currently, lecanemab is being studied in a confirmatory Phase 3 clinical study in symptomatic early AD (Clarity-AD), following the outcome of the Phase 2 clinical study (Study 201). Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing. Furthermore, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007.
* Developed by Eisai, ADCOMS (AD Composite Score) combines items from the ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale), CDR (Clinical Dementia Rating) and the MMSE (Mini-Mental State Examination) scales to enable a sensitive detection of changes in clinical functions of early AD symptoms and changes in memory. The ADCOMS scale ranges from a score of 0.00 to 1.97, with higher score indicating greater impairment.
** An 80% or higher estimated probability of demonstrating 25% or greater slowing in clinical decline at 12 months treatment measured by ADCOMS from baseline compared to placebo.
2. About the Collaboration between Eisai and Biogen for Alzheimer's Disease
3. About the Collaboration between Eisai and BioArctic for Alzheimer's Disease
4. About Eisai Co., Ltd.
Leveraging the experience gained from the development and marketing of a treatment for Alzheimer's disease, Eisai aims to establish the "Eisai Dementia Platform." Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a "Dementia Ecosystem," by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com.
5. About Biogen
In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil fuels across the company's operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities.
The company routinely posts information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow Biogen on social media – Twitter, LinkedIn, Facebook, YouTube.
Biogen Safe Harbor
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies, including the Clarity AD clinical trial and AHEAD 3-45 study; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen's business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
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