STOCKHOLM, Aug. 25, 2025 /PRNewswire/ — The Alzheimer’s treatment landscape is shifting in Europe. BioArctic AB (publ) (NASDAQ Stockholm: BIOA B)’s partner, Eisai, announced today the European launch of Leqembi, starting with Austria on August 25, 2025, followed by Germany on September 1, 2025. This marks a significant step for the drug, which secured European Commission (EC) approval in April 2025 as the first therapy to target an underlying cause of Alzheimer’s disease (AD). Leqembi is indicated for adult patients experiencing mild cognitive impairment (MCI) and mild dementia due to AD (early AD), specifically those who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology. The launches in Germany and Austria represent the initial rollout within the EU for this potentially groundbreaking treatment.
Eisai has been working hand-in-glove with regional and local healthcare authorities since EC approval to fulfill the mandatory authorization prerequisites ahead of launch. A critical component of this process has been the implementation of a controlled access program, now active in both Austria and Germany, facilitating the launch in these pioneering EU nations.
Alzheimer’s, characterized by amyloid-beta (Aβ) plaques and tau tangles, poses a relentless and growing challenge. As the disease progresses through stages of increasing severity, new therapeutic avenues are urgently needed to slow its trajectory. Leqembi distinguishes itself by targeting not only amyloid plaques but also protofibrils, which are believed to have a crucial role in downstream Tau accumulation. This dual-action approach presents a novel strategy.
Data from the Clarity AD clinical trial provided strong evidence for Leqembi’s efficacy. The trial’s primary endpoint focused on the Clinical Dementia Rating – Sum of Boxes (CDR-SB), a key measure of global cognitive and functional decline. Among the EU indicated population (ApoE ε4 non-carriers or heterozygotes), treatment with lecanemab (n=757) resulted in a 31% reduction in clinical decline on the CDR-SB scale at 18 months, compared to the placebo group (n=764). This indicates a notable slowing of disease progression.
As with any drug, Leqembi is associated with potential adverse reactions. In the EU indicated population (ApoE ε4 non-carriers or heterozygotes) (n=757), the most common were infusion-related reactions (26%), ARIA-H (13%), headache (11%) and ARIA-E (9%). Symptomatic ARIA-E occurred in 2% of participants, while symptomatic ARIA-H occurred in 0.8% of patients. ARIA refers to Amyloid-Related Imaging Abnormalities, representing swelling or bleeding in the brain, a known side effect with lecanemab treatment.
Leqembi represents the culmination of a long-term partnership between BioArctic and Eisai. The antibody was initially developed by BioArctic based on groundbreaking research by Professor Lars Lannfelt and his team. While Eisai takes the lead on clinical development, market approval applications, and global commercialization, BioArctic retains the right to commercialize Leqembi in the Nordic region, where the two companies are collaborating on a joint commercialization strategy.
About lecanemab (Leqembi®)
Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody that selectively binds to aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). The strategic research alliance between BioArctic and Eisai yielded the development of Lecanemab.
Lecanemab has received approval in the U.S., Japan, EU, China, Great Britain, and several other markets for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia. Lecanemab’s approvals in these countries, as well as the EC’s market authorization, were 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. 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 which 1,521 were in the recommended indicated population in the label in the European Union (ApoE ε4 heterozygotes or non-carriers). 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.
The primary endpoint was the global cognitive and functional scale, CDR-SB In the Clarity AD clinical trial, treatment with lecanemab (n=757), in the EU indicated population (ApoE ε4 non-carriers or heterozygotes, measured by control-based multiple imputation), reduced clinical decline on CDR-SB by 31% at 18 months compared to placebo (n=764). The mean CDR-SB score at baseline was approximately 3.2 in both groups. 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). 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.
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. 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). The ADCS MCI-ADL assesses the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. Amyloid Positron Emission Tomography (PET) using Centiloids and ADAS-Cog14 also showed highly statistically significant results compared with placebo (Pi
In the EU indicated population (ApoE ε4 heterozygotes or non-carriers), 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.
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, Eisai’s Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and 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. 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.
About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer’s disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer’s disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer’s disease. BioArctic has the right to commercialize lecanemab in the Nordic region and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer’s disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world’s first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer’s disease. Leqembi has been developed together with BioArctic’s partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson’s disease and ALS as well as additional projects against Alzheimer’s disease. Several of the projects utilize the company’s proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic’s B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.
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