Eisai And Biogen Inc. Announce U.S. FDA Grants Breakthrough Therapy Designation For Lecanemab (BAN2401), An Anti-Amyloid Beta Protofibril Antibody For The Treatment Of Alzheimer's Disease
TOKYO and CAMBRIDGE, Mass., June 23, 2021 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD).
Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. The benefits of a Breakthrough Therapy designation include more intensive guidance on an efficient development program as well as eligibility for rolling review and potentially priority review.
The FDA's Breakthrough Therapy designation for lecanemab is based on the recently published results of a Phase 2b clinical trial (Study 201) of 856 patients with mild cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology.1 The proof-of-concept Study 201 explored the impact of treatment with lecanemab on reducing brain amyloid beta (Aβ) and clinical decline. In this study, pre-specified analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses.
In March 2021 Eisai and Biogen completed enrollment of 1,795 patients with early AD in the Clarity AD study. The study's primary endpoint is expected to be completed by the end of September 2022. Additionally, the Phase 3 clinical study, AHEAD 3-45, is currently exploring lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains. Open label extension data from Study 201 confirmed time-dependent reduction of brain Aβ in individuals newly treated with lecanemab and was presented at the 2021 Alzheimer's Disease and Parkinson's Disease Conference.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.
Biogen Safe Harbor Statement
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 trials; 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.
[Notes to editors]
About Lecanemab (BAN2401)
About the Collaboration between Eisai and Biogen for Alzheimer's Disease
About the Collaboration between Eisai and BioArctic for Alzheimer's Disease
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.
View original content:http://www.prnewswire.com/news-releases/eisai-and-biogen-inc-announce-us-fda-grants-breakthrough-therapy-designation-for-lecanemab-ban2401-an-anti-amyloid-beta-protofibril-antibody-for-the-treatment-of-alzheimers-disease-301318796.html
SOURCE Eisai Inc.
Company Codes: NASDAQ-NMS:BIIB