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Leqembi® (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer’s Disease to be Authorised in the European Union

April 16, 2025 – Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical – Alzheimer's Disease, Biogen, Eisai, European Commission, marketing authorisation

In the European Union (EU), lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) (early AD) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes with confirmed amyloid pathology
Lecanemab is the first therapy that targets an underlying cause of the disease to be authorised in the EU for eligible people with early AD
Authorisation is primarily based on data from the global Phase 3 clinical trial, Clarity AD, which demonstrated that lecanemab slowed disease progression in early AD vs placebo at 18 months
The European Commission’s decision brings access to lecanemab one step closer for eligible people with early AD in the EU.

16 April, 2025 — Hatfield, UK and Massachusetts, US — Eisai Europe Ltd. and Biogen Inc. announced today that the European Commission (EC) has granted Leqembi (lecanemab) Marketing Authorisation (MA) in the European Union (EU). This makes the medicine the first therapy that targets an underlying cause of Alzheimer’s disease (AD) to be granted a MA in the EU.

Lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to AD (early AD) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes with confirmed amyloid pathology. Early AD is usually the first stage of the disease, where symptoms become noticeable. Today’s MA applies to all 27 EU Member States as well as Iceland, Liechtenstein and Norway.

Lecanemab is an amyloid-beta (Aβ) monoclonal antibody that preferentially binds and clears toxic protofibrils** (soluble Aβ aggregates), in addition to targeting and reducing Aβ plaques (insoluble Aβ aggregates). Aβ protofibrils are a key toxic form of Aβ that accumulate in the brain and cause neuronal injury.

AD is a neurodegenerative disease that progresses in stages and increases in severity over time, and each stage of the disease presents different challenges for those living with AD and their care partners. Early symptoms can include forgetting recent events or conversations. As AD progresses, everyday activities, hobbies and social engagements become more challenging, and independence is lost. Early detection and diagnosis of AD can provide opportunities for interventions and support to be put in place for those in the early stages of the disease.

“Today’s decision makes lecanemab the first treatment option in the European Union that can slow the progression of early Alzheimer’s disease and is a key step to making the medicine available to eligible patients. This is important news for those in the clinical and research Alzheimer’s community who are dedicated to improving the management of a disease which poses a significant burden to healthcare systems and society,” said Gary Hendler, Regional Chairman and CEO, Eisai EMEA, Senior Vice President & Global Corporate Officer, Eisai Co. Ltd, Tokyo. “We are proud that our heritage of over 40 years in dementia has led to this milestone, as we aim to be part of the solution for a better future for those impacted by this disease.”

“The European Commission’s authorisation of lecanemab represents a significant milestone in addressing this progressive disease,” said Wolfram Schmidt, President and Head of Europe at Biogen. “We are proud there is now an approved treatment in the European Union that can slow the progression of early Alzheimer’s disease. Our team at Biogen remains dedicated to standing with the Alzheimer’s community, working collectively to achieve meaningful advancements in patient care.”

“Eisai will work collaboratively with national reimbursement authorities and healthcare providers to support access for eligible patients in European Union countries as soon as possible,” said Nick Burgin, President & COO, President Global Value & Access, Eisai EMEA. “Achieving optimal outcomes for people treated with the medicine is of paramount importance. To help achieve this, we are working with the European Medicines Agency and relevant national organisations to put measures in place to support the appropriate use of lecanemab as soon as it is introduced into each European Union country.”

The EC authorisation was primarily based on Phase 3 data from Eisai’s global, placebo-controlled, double-blind, parallel-group, randomised Clarity AD clinical trial, in which the medicine met its primary endpoint (change from baseline in the Clinical Dementia Rating Sum of Boxes [CDR-SB]^† at 18 months), demonstrating that lecanemab slowed disease progression in early AD vs placebo,and all key secondary endpoints.

In the indicated population in the Clarity AD clinical trial, the most common adverse events in the treatment group (n=757) were infusion-related reaction, amyloid-related imaging abnormalities with haemorrhage (small spots of bleeding) (ARIA-H)^‡, headache and amyloid-related imaging abnormalities with cerebral oedema (build-up of fluid) (ARIA-E)^‡‡.

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co-commercialising 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 MA Holder. In the Nordic countries, Eisai and BioArctic will co-promote the medicine, with Eisai distributing the product as the MA Holder.

About Eisai EMEA

At Eisai, we give our first thought to patients, their care partners and to society, to increase the benefits health care provides them – we call this human health care (hhc). We focus beyond the realm of health to the value we bring to society. Through the power of collaboration and by using insights to guide our work, we can make a meaningful contribution to people and society, and to improve outcomes and services for all. In EMEA, we are the European hub of Tokyo-based Eisai Co. Ltd., forming part of a multinational team working across a global network of R&D facilities, manufacturing sites and marketing subsidiaries. Our collective passion and dedication to patient care is the driving force behind our efforts to discover and develop innovative medicines in a variety of therapeutic areas where a high unmet medical need remains, including oncology and neurology. Our mission is clear; we strive to make a significant long-lasting contribution to society in an ethical, compliant, and sustainable way by embodying hhc in everything we do. For more information about Eisai in the EMEA region please visit www.eisai.eu.

5. About Biogen

Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities with aspirations to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. Visit: www.biogen.com.