#Sweden #Stockholm #Leqembi #BioArctic #Alzheimer’s

Leqembi® Launches in the EU: A New Hope for Alzheimer's Patients

On August 25, 2025, a significant milestone in Alzheimer's treatment was reached as BioArctic AB's partner, Eisai, announced the launch of Leqembi® (lecanemab) in the European Union, beginning in Austria. The drug is set to arrive in Germany shortly after on September 1, 2025, marking a pivotal moment for the treatment of early-stage Alzheimer's disease (AD).

A Revolutionary Therapy

Leqembi has garnered attention as the first therapy approved by the European Commission (EC) targeting the underlying cause of Alzheimer’s. It is indicated for adults diagnosed with mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease, particularly in patients who do not carry the apolipoprotein E ε4 (ApoE ε4) gene or are heterozygotes with verified amyloid pathology. The launch signifies a pioneering approach where the focus shifts to treating the disease's root rather than merely addressing symptoms.

With Alzheimer’s disease continually becoming a growing concern, characterized by its progressive nature and the significant burden it imposes on patients and their caregivers, the need for effective treatments has reached a critical level. Leqembi is unique, as it simultaneously targets amyloid plaques and protofibrils—two elements that contribute to the disease’s advancement and ultimately aim to reduce tau protein accumulation in the brain.

Collaboration and Development

The development of Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, initiated back in 2005. Under this partnership, BioArctic developed the antibody based on research conducted by Professor Lars Lannfelt, who discovered the Arctic mutation linked to Alzheimer’s. Eisai has taken on responsibilities regarding clinical development, regulatory approvals, and commercialization, particularly in markets outside the Nordic region where BioArctic holds commercialization rights.

Clinical Success and Patient Insights

Eisai's Clarity AD clinical trial served as a foundation for Leqembi’s efficacy, illustrating significant results in slowing cognitive decline. The trial involved 1,795 patients, with data showcasing that treatment with lecanemab resulted in a 31% reduction in clinical decline, as measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB). Most notably, for the targeted EU demographic, the most prevalent side effects reported were infusion-related reactions and cases of amyloid-related imaging abnormalities (ARIA), emphasizing the need for monitored implementations in clinical settings.

Looking Ahead

This launch represents a new chapter for Alzheimer’s care in Europe, as it initiates broader discussions on how emerging therapies can innovate the management of neurodegenerative diseases. Following initial launches, the focus will remain on establishing a network of local healthcare authorities to ensure Leqembi's safe and effective distribution throughout Europe.

BioArctic and Eisai's partnership continues to pave the way for potential advancements in current treatment frameworks while balancing the trials and successes of clinical interventions. Leqembi is not just another drug on the market; it is a beacon of hope for families affected by Alzheimer's disease. More launches in various countries are anticipated as this drug gains traction in the global market, reflecting an urgent commitment to combating one of the most challenging health concerns of our time.