Leqembi®: A Significant Advancement in Alzheimer's Treatment in the Nordics

On October 14, 2025, BioArctic AB (NASDAQ Stockholm: BIOA B) heralded a new era in Alzheimer's treatment with the announcement that Leqembi® (lecanemab) has been made available at a private clinic in Finland. The very first patient has commenced treatment, marking an essential milestone in the pharmacological landscape of the Nordic countries, an area where innovative healthcare solutions have been increasingly sought after.

BioArctic has partnered with Eisai for the promotion and distribution of Leqembi throughout the Nordic region, showcasing a strategic progression as the company aims to establish itself as a leading pharmaceutical entity in Sweden. Gunilla Osswald, CEO of BioArctic, expressed her enthusiasm over this development, emphasizing the pressing demand for effective treatment options that can slow the progression of Alzheimer's disease. She pointed out the significant benefits this innovation could provide to patients, their caregivers, and society at large.

The approval of Leqembi by the European Commission (EC) in April 2025 was historic, as it has become the first therapy focused on addressing a fundamental cause of Alzheimer's disease (AD). This treatment is specifically indicated for adults who have been clinically diagnosed with mild cognitive impairment (MCI) and early dementia due to AD, particularly for those who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology.

Following the EC approval, BioArctic and Eisai meticulously collaborated with Nordic healthcare authorities to fulfill the mandatory authorization requirements. The launch of a controlled access program was initiated in Finland, allowing private clinics such as Terveystalo Ruoholahti to treat patients with early Alzheimer's disease effectively. In addition, ongoing assessments are being made for Leqembi's inclusion in the public healthcare system, which further underscores the urgency and relevance of this treatment.

The importance of treating Alzheimer's disease cannot be understated, as it is a progressive and debilitating condition impacting millions worldwide. Its underlying mechanisms involve amyloid-beta (Aβ) and tau protein accumulation, contributing to cognitive decline and neurological degeneration. Leqembi stands out as the only approved treatment that effectively combats Alzheimer's disease by targeting both protofibrils and amyloid plaques, influencing the tau pathology downstream.

Leqembi's development is the result of a remarkable collaboration between BioArctic and Eisai, with the initial research spearheaded by Professor Lars Lannfelt at Uppsala University, Sweden. This partnership has paved the way for the antibody's clinical development, regulatory applications, and eventual commercialization in the Nordic region. As BioArctic prepares for a joint commercialization initiative with Eisai, both companies remain committed to expanding access to this groundbreaking treatment.

The clinical validation of Leqembi is backed by significant findings from the global Clarity AD clinical trial. This Phase 3 study included 1,795 participants diagnosed with early Alzheimer's disease, providing substantial evidence for the drug's efficacy. Results demonstrated that treatment with lecanemab reduced cognitive decline by 31% at the 18-month mark when compared to placebo. Other measures, such as the AD Cooperative Study-Activities of Daily Living Scale, indicated a 33% lesser decline in daily living activities among lecanemab recipients compared to their counterparts receiving a placebo.

Analyses conducted among the European Union's indicated population highlighted infusion-related reactions as the most frequent adverse event, occurring in 26% of patients. Despite experiencing some side effects, the clear clinical benefits of Leqembi outweigh the potential risks, particularly for those in the early stages of Alzheimer's disease.

With approvals spanning across 50 countries, including the U.S., Japan, China, and several European nations, lecanemab is poised to alter how Alzheimer's disease is treated globally. The pathway towards achieving widespread effectiveness and patient access continues as BioArctic and Eisai tackle additional regulatory reviews and public health integration.

In conclusion, the introduction of Leqembi into the Nordic healthcare framework represents a substantial leap forward against Alzheimer's disease, delivering hope to countless individuals striving for improved cognitive health. This treatment not only underscores decades of committed research and collaboration but also serves as a testament to the potential of scientific innovation in addressing pressing healthcare challenges.