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Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of E
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# Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer's Disease in Japan **Date:** 2025-11-27 19:30:00 **Company:** Biogen Inc. **Ticker:** BIIB **Source URL:** https://www.globenewswire.com/news-release/2025/11/28/3195968/0/en/Eisai-Submits-New-Drug-Application-for-Subcutaneous-Formulation-of-LEQEMBI-for-the-Treatment-of-Early-Alzheimer-s-Disease-in-Japan.html --- [Accessibility: Skip TopNav](https://www.globenewswire.com/news-release/2025/11/28/3195968/0/en/Eisai-Submits-New-Drug-Application-for-Subcutaneous-Formulation-of-LEQEMBI-for-the-Treatment-of-Early-Alzheimer-s-Disease-in-Japan.html#maincontainer) [](https://www.globenewswire.com/) - [Newsroom](https://www.globenewswire.com/newsroom) - [Services](https://www.globenewswire.com/services) - [Contact Us](https://insight.notified.com/globenewswire-contact-us?utm_medium=Website&...
# Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer's Disease in Japan **Date:** 2025-11-27 19:30:00 **Company:** Biogen Inc. **Ticker:** BIIB **Source URL:** https://www.globenewswire.com/news-release/2025/11/28/3195968/0/en/Eisai-Submits-New-Drug-Application-for-Subcutaneous-Formulation-of-LEQEMBI-for-the-Treatment-of-Early-Alzheimer-s-Disease-in-Japan.html --- [Accessibility: Skip TopNav](https://www.globenewswire.com/news-release/2025/11/28/3195968/0/en/Eisai-Submits-New-Drug-Application-for-Subcutaneous-Formulation-of-LEQEMBI-for-the-Treatment-of-Early-Alzheimer-s-Disease-in-Japan.html#maincontainer) [](https://www.globenewswire.com/) - [Newsroom](https://www.globenewswire.com/newsroom) - [Services](https://www.globenewswire.com/services) - [Contact Us](https://insight.notified.com/globenewswire-contact-us?utm_medium=Website&utm_source=Contact%20Us&utm_campaign=Contact%20Us%20ENG) - [About Us](https://www.globenewswire.com/about) - English [Sign In](https://www.globenewswire.com/home/signin) [Register](https://portal.notified.com/en/registration) # [](https://www.biogen.com/) # Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer’s Disease in Japan ## If approved, lecanemab would be the first and only anti-amyloid treatment in Japan to offer an at-home injection from the initiation of treatment for this progressive, relentless disease November 27, 2025 19:30 ET\| Source: [Biogen Inc.](https://www.globenewswire.com/en/search/organization/Biogen%2520Inc%C2%A7)FollowBiogen Inc. * * * Share - * * * TOKYO and CAMBRIDGE, Mass., Nov. 27, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that Eisai has filed a new drug application for “LEQEMBI®” (brand name, generic name: lecanemab) seeking approval for a subcutaneous formulation (subcutaneous autoinjector: SC-AI) as a new route of administration to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). The application is based on data from multiple subcutaneous (SC) administration sub-studies of lecanemab conducted as part of the Phase 3 Clarity AD open-label extension (OLE), following the 18-month core study in individuals with Mild Cognitive Impairment (MCI) due to Alzheimer‘s disease (AD) or mild stage of AD dementia (collectively referred to as early AD). It was confirmed that the once-weekly administration of SC-AI 500mg resulted in equivalent exposure to once every two weeks intravenous (IV) administration and similar clinical and biomarker benefits. Subcutaneous administration demonstrated a safety profile similar to IV administration, with less than 2% incidence of systemic injection/infusion-related reactions. If approved, the SC-AI of 500 mg (two 250 mg injections) could be used to administer a once-weekly dose at home from the initiation of treatment, as an alternative to the current IV administration every two weeks dose in the hospital setting. The potential approval of SC-AI would expand the option for patients and care partners to receive LEQEMBI treatment at home. The injection time for each autoinjector (250mg injection) is approximately 15 seconds. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as preparation for infusion and nurse monitoring, while streamlining the overall AD treatment care pathway. AD is a progressive, relentless disease with amyloid beta (Aβ) and tau as hallmarks that is caused by a continuous underlying neurotoxic process driven by protofibrils\* that begins before amyloid plaque accumulation and continues after plaque removal.1,2,3 Only LEQEMBI fights AD in two ways – targeting both protofibrils and amyloid plaque, which can impact tau downstream. LEQEMBI is currently approved in 51 countries and regions and is under regulatory review in 9 countries. Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. \*Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.1 Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.2 | | | | --- | --- | | **MEDIA CONTACTS** | | | **Eisai Co., Ltd.**<br>Public Relations Department<br>TEL: +81 (0)3-3817-5120<br>**Eisai Europe, Ltd.**<br>EMEA Communications Department<br>+44 (0) 797 487 9419<br>[Emea-comms@eisai.net](mailto:Emea-comms@eisai.net "Emea-comms@eisai.net")<br>**Eisai Inc. (U.S.)**<br>Libby Holman<br>+1-201-753-1945<br>[Libby\_Holman@Eisai.com](mailto:Libby_Holman@Eisai.com "Libby_Holman@Eisai.com") | **Biogen Inc.**<br>Madeleine Shin <br>+1-781-464-3260<br>[public.affairs@biogen.com](mailto:public.affairs@biogen.com "public.affairs@biogen.com") | | **INVESTOR CONTACTS** | | | **Eisai Co., Ltd.**<br>Investor Relations Department<br>TEL: +81 (0) 3-3817-5122 | **Biogen Inc.**<br>Tim Power<br>\+ 1-781-464-2442<br>[IR@biogen.com](mailto:IR@biogen.com "IR@biogen.com") | **Notes to Editors** 1. **About lecanemab (generic name, brand name: LEQEMBI** **®** **)** Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab has been approved in 51 countries and regions including Japan, the United States, Europe, China, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 9 countries. Leqembi received manufacturing and marketing approval in Japan on September, 2023 for the indication of a treatment for slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in the U.S., China, he United Kingdom, and others, and applications have been filed in 4 countries and regions. The U.S. FDA approved Eisai’s Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. A rolling Supplemental Biologics License Application (sBLA) for initiation treatment was initiated under Fast Track status in September 2025, and completed in November 2025. 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 AD (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 and includes lecanemab as the backbone anti-amyloid therapy. 2. **About the Collaboration between Eisai and Biogen for AD** Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. 3. **About the Collaboration between Eisai and BioArctic for AD** Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015. 4. **About Eisai Co., Ltd.** Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as _human health care_ ( _hhc_) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. 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Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors. **References** 1. Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. _Nat Commun_. 2021;12:3451. doi:10.1038/s41467-021-23507-z 2. Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. _Int J Mol Sci._ 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706. 3. Hampel H, Hardy J, Blennow K, et al. The amyloid pathway in Alzheimer's disease. _Mol Psychiatry._ 2021;26(10):5481-5503.  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