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Austria and Germany to become the first markets in the European Union (EU) to launch LEQEMBI® (lecan
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# Austria and Germany to become the first markets in the European Union (EU) to launch LEQEMBI® (lecanemab) **Date:** 2025-08-25 03:00:00 **Company:** Biogen Inc. **Ticker:** BIIB **Source URL:** https://www.globenewswire.com/news-release/2025/08/25/3138217/0/en/Austria-and-Germany-to-become-the-first-markets-in-the-European-Union-EU-to-launch-LEQEMBI-lecanemab.html --- [Accessibility: Skip TopNav](https://www.globenewswire.com/news-release/2025/08/25/3138217/0/en/Austria-and-Germany-to-become-the-first-markets-in-the-European-Union-EU-to-launch-LEQEMBI-lecanemab.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.globen...
# Austria and Germany to become the first markets in the European Union (EU) to launch LEQEMBI® (lecanemab) **Date:** 2025-08-25 03:00:00 **Company:** Biogen Inc. **Ticker:** BIIB **Source URL:** https://www.globenewswire.com/news-release/2025/08/25/3138217/0/en/Austria-and-Germany-to-become-the-first-markets-in-the-European-Union-EU-to-launch-LEQEMBI-lecanemab.html --- [Accessibility: Skip TopNav](https://www.globenewswire.com/news-release/2025/08/25/3138217/0/en/Austria-and-Germany-to-become-the-first-markets-in-the-European-Union-EU-to-launch-LEQEMBI-lecanemab.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/) # Austria and Germany to become the first markets in the European Union (EU) to launch LEQEMBI® (lecanemab) August 25, 2025 03:00 ET\| Source: [Biogen Inc.](https://www.globenewswire.com/en/search/organization/Biogen%2520Inc%C2%A7)FollowBiogen Inc. * * * Share - * * * TOKYO and CAMBRIDGE, Mass., Aug. 25, 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 the anti-amyloid beta (Aβ) monoclonal antibody “LEQEMBI®” has been launched in Austria on August 25, 2025 and will be launched in Germany on September 1, 2025. LEQEMBI received the European Commission (EC) approval in April 2025 as the first therapy that targets an underlying cause of Alzheimer’s disease (AD). It is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to AD ( collectively referred to as early AD) who are apolipoprotein E ε4 (ApoE ε4\*) non-carriers or heterozygotes with confirmed amyloid pathology.1 Germany and Austria will mark the first launches in the EU. Following the EC approval, Eisai has been collaborating with the regional and local healthcare authorities to implement the mandatory authorisation requirements ahead of launch. The required controlled access program\*\* is now in place in Austria and Germany, enabling the launch in these first two EU countries. AD is a progressive, relentless disease with Aβ and tau as hallmarks. AD progresses in stages that increase in severity over time, and each stage of the disease presents different challenges for those living with AD and their care partners. There is a significant unmet need for new treatment options that slow the progression of AD by initiating therapy from its early stage and continuing it in order to reduce the overall burden on people affected by AD and society. Only LEQEMBI fights AD in two ways - targeting both amyloid plaque and protofibrils\*\*\*, which can impact tau downstream. In the Clarity AD clinical trial, the primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating – Sum of Boxes (CDR-SB).1 Treatment with lecanemab (n=757), in the EU indicated population (ApoE ε4 non-carriers or heterozygotes, measured by controlled-based multiple imputation†), reduced clinical decline on CDR-SB by 31% at 18 months compared to placebo (n=764).1 In the EU indicated population (ApoE ε4 non-carriers or heterozygotes) (n=757), the most common adverse reactions were infusion-related reaction (26%), ARIA-H (13%), headache (11%) and ARIA-E (9%). Symptomatic ARIA-E occurred in 2% of participants. Symptomatic ARIA-H occurred in 0.8% of patients.1 Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. In the EU (excluding the Nordic countries), Eisai and Biogen will co-promote the medicine, with Eisai distributing the product as the Marketing Authorization Holder. \\* Apolipoprotein E is a protein involved in the metabolism of lipid in humans. It is implicated in AD. People with only one (heterozygous) or no copy (non-carriers) of the ApoE ε4 gene are less likely to experience ARIA than people with two ApoE ε4 copies (homozygous).2 ARIA is a recognized important side effect with lecanemab that involves swelling and potential bleeding in the brain.1,2 \\*\\* Controlled access program is a system that restricts the use and distribution of certain medicines. It is designed to promote the appropriate use of medicines while ensuring patient safety. In line with the EC approval requirements, initiation of lecanemab treatment should be through a central registration system implemented as part of CAP. \\*\\*\\* 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.3 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.3,4 † As requested by the regulatory authority, efficacy analyses were conducted for ApoE ε4 non-carriers or heterozygotes participants using control-based multiple imputation method, in which all missing values were imputed with copy-increments (change between visits) using the actual value in placebo group.5 This methodology differs from that used in the Clarity AD primary analysis which used mixed-model repeat measures (MMRM) with missing at random assumption.2 Leqembi®▼ : This medicine is subject to additional monitoring. This allows for rapid identification of new findings on safety. Healthcare professionals are asked to report any suspected side effects. | | | | --- | --- | | **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 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).1,2 The EC’s authorization was primarily based on Phase 3 data from Eisai’s global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results.1,2 Clarity AD was a Phase 3 global, placebo-controlled, double-blind, parallel-group, randomized study in 1,795 patients with early AD (MCI or mild dementia due to AD, with confirmed presence of amyloid pathology). Of the total number of patients randomized, 1,521 were in the EU indicated population (ApoE ε4 non-carriers or heterozygotes).2 The treatment group was administered lecanemab 10 mg/kg bi-weekly, with participants allocated in a 1:1 ratio to receive either placebo or lecanemab for 18 months.2 The primary endpoint was the global cognitive and functional scale, CDR-SB.2 In the Clarity AD clinical trial, treatment with lecanemab (n=757), in the EU indicated population (ApoE ε4 non-carriers or heterozygotes, measured by controlled-based multiple imputation), reduced clinical decline on CDR-SB by 31% at 18 months compared to placebo (n=764).1 The mean CDR-SB score at baseline was approximately 3.2 in both groups.1 The adjusted least-squares mean change from baseline at 18 months was 1.217 with lecanemab and 1.752 with placebo (difference, −0.535; 95% confidence interval \[CI\], −0.778 to −0.293).1 CDR-SB is a global cognitive and functional scale that measures six domains of functioning, including memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care.6 In addition, the secondary endpoint from the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL), which measures information provided by people caring for patients with AD, noted 33% less decline compared to placebo at 18 months.1 The adjusted mean change from baseline at 18 months in the ADCS MCI-ADL score was −3.873 in the lecanemab group and −5.809 in the placebo group (difference, 1.936; 95% CI, 1.029 to 2.844).1 The ADCS MCI-ADL assesses the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities.7 Amyloid Positron Emission Tomography (PET) using Centiloids and ADAS-Cog14 also showed highly statistically significant results compared with placebo (P<0.001).1 In the EU indicated population (ApoE ε4 non-carriers or heterozygotes) (n=757), the most common adverse reactions were infusion-related reaction (26%), ARIA-H (13%), headache (11%) and ARIA-E (9%). Symptomatic ARIA-E occurred in 2% of participants. Symptomatic ARIA-H occurred in 0.8% of patients.1 Lecanemab has been approved in 48 countries and is under regulatory review in 10 countries. In January 2025, the supplemental Biologics License Application (sBLA) for intravenous (IV) maintenance dosing of the treatment was approved in the U.S., and application have been filed in 9 countries and regions. Additionally, the U.S. Food and Drug Administration (FDA) accepted Eisai’s Biologics License Application (BLA) for the LEQEMBI subcutaneous autoinjector for weekly maintenance dosing in January 2025 and set a PDUFA action date for August 31, 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. **Application specifics** **1**To ensure the safe and effective use of lecanemab and to support its use in accordance with the approval, all prescribers and patients must be enrolled in a controlled access programme before starting treatment. Physicians should recommend that patients participate in the collection of data from clinical practice (e.g. in reg-istries) to further improve understanding of Alzheimer's disease and the effects of appropriate therapies. Patients will receive the Leqembi package leaflet and a patient card to carry with them at all times when they start treatment. They must be informed about the risks of lecanemab treatment, the necessary monitoring by MRI scans and the signs or symptoms of ARIA, and should be encouraged to report these symptoms and signs urgently. 3. **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. 4. **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 back-up was signed in May 2015. 5. **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. In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners. 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Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. **References** 1. European Medicines Agency Summary of Product Characteristics （SmPC） 2. van Dyck, C.H., _et al_. Lecanemab in Early Alzheimer’s Disease. _New England Journal of Medicine_. 2023;388:9-21. [https://www.nejm.org/doi/full/10.1056/NEJMoa2212948](https://www.globenewswire.com/Tracker?data=JIvICH3385044KeVaLcnyk8A16s1f6vdt9vLgCdWFImPo99mkUJA7XoR1GrvXf04ojAHK9kt6IqDOYGq33SVd6MEc9ErxJo-63VDXEliGFJvMfU9H6Dv-9p8180rW1wUFCemiLsXGiSG7OqoYwahiZ5V-LhEr9me2QYcnzJC8nY= ""). 3. 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. 4. 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. 5. Froelich L., _et al._ Lecanemab for treatment of individuals with early Alzheimer’s disease (AD) who are apolipoprotein E E4 (ApoE e4) non-carriers of heterozygotes. Poster presented at German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) conference, November 2024 6. Morris, J.C. The Clinical Dementia Rating (CDR): current version and scoring rules. _Neurology_. 1993;43:2412-2414. 7. Pedrosa, H., _et al_. Functional evaluation distinguishes MCI patients from healthy elderly people–the ADCS/MCI/ADL scale. _The Journal of Nutrition, Health and Aging_. 2010;14(8):703–9.  GlobeNewswire Company ProfileBiogen Inc.Industry: BiotechnologyWebsite: [https://www.biogen.com/](https://www.biogen.com/) Press Release Actions - [Print](https://www.globenewswire.com/news-release/2025/08/25/3138217/0/en/Austria-and-Germany-to-become-the-first-markets-in-the-European-Union-EU-to-launch-LEQEMBI-lecanemab.html?print=1) - [Download PDF](https://www.globenewswire.com/news-release/2025/08/25/3138217/0/en/Austria-and-Germany-to-become-the-first-markets-in-the-European-Union-EU-to-launch-LEQEMBI-lecanemab.html?pdf=1) - [Subscribe via RSS](https://www.globenewswire.com/rssfeed/organization/hNQxyS-FvexsgfoXWT62ZA==) - [Subscribe via ATOM](https://www.globenewswire.com/atomfeed/organization/hNQxyS-FvexsgfoXWT62ZA==) - [Javascript](https://www.globenewswire.com/JSWidget/organization/SRHNIWE5hsiXGQWmHHZB3w%3d%3d) ## Recommended Reading - March 31, 2026 06:59 ET\|Source: [Biogen Inc.](https://www.globenewswire.com/en/search/organization/Biogen%2520Inc%C2%A7) [Biogen to Acquire Apellis, Enhancing the Company’s Growth Portfolio in Immunology and Rare Disease, Bolstering Growth Outlook and Accelerating Expansion into Nephrology](https://www.globenewswire.com/news-release/2026/03/31/3265288/0/en/Biogen-to-Acquire-Apellis-Enhancing-the-Company-s-Growth-Portfolio-in-Immunology-and-Rare-Disease-Bolstering-Growth-Outlook-and-Accelerating-Expansion-into-Nephrology.html) Acquisition will bring two differentiated commercialized immunology medicines to Biogen with EMPAVELI® FDA-approved in three indications, including two rare kidney diseases, and SYFOVRE® FDA-approved... 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