Leqembi® (lecanemab) Marks a New Era in Alzheimer's Treatment with EU Launch

Leqembi® (lecanemab) Launches in the EU

On August 25, 2025, the first therapy targeting the underlying causes of Alzheimer’s disease, Leqembi® (lecanemab), was officially launched in the European Union. This significant event took place in Austria and will expand to Germany on September 1, 2025. Approved by the European Commission in April 2025, Leqembi stands out as the first treatment aimed at adults diagnosed with mild cognitive impairment (MCI) or mild dementia resulting from Alzheimer’s, specifically for patients who do not have certain genetic markers that increase their risk of adverse effects.

The urgency behind this launch is evident, as Alzheimer's disease continues to be a progressive condition that deeply impacts both patients and caregivers. As the disease develops, it poses escalating challenges, highlighting a dire need for effective treatments that can slow its progression and alleviate societal burdens.

Leqembi acts on two crucial mechanisms: it targets amyloid plaques, known culprits in Alzheimer’s pathology, and protofibrils, forms of amyloid-beta that cause significant neuronal damage. By addressing both, Leqembi could offer a new ray of hope to those afflicted with early-stage Alzheimer’s.

In clinical trials, such as the notable Clarity AD study, lecanemab demonstrated a 31% reduction in clinical decline over 18 months in the relevant patient population compared to a placebo. This impressive outcome measured cognitive and functional capacity, reinforcing the potential of Leqembi in real-world settings.

As is customary with new treatments, some adverse reactions were reported. The most common included infusion-related reactions, highlighting the importance of monitoring during the treatment process. However, the benefits of slowed cognitive decline may outweigh these risks, providing a viable option for those with early-onset Alzheimer’s, particularly apolipoprotein E ε4 non-carriers or heterozygotes.

The pathway to this launch has been marked by collaboration between BioArctic AB, the innovator behind Leqembi, and their partner Eisai. Since 2005, these two companies have synergized their efforts to develop and commercialize breakthrough therapies for Alzheimer’s disease. Their most significant agreements paved the way for bringing lecanemab to the market.

BioArctic’s expertise lies in addressing various neurodegenerative diseases, and with Eisai's extensive capabilities in clinical development and regulatory approvals, they have fostered an environment conducive to innovation. Looking ahead, they are poised to prepare for a broader release across the Nordic region with collaborative commercialization efforts.

As the first of its kind, Leqembi marks a pivotal advancement in the treatment landscape for Alzheimer’s disease. The dual-target approach that this therapy utilizes sets it apart from traditional treatments and could significantly affect how this debilitating condition is managed in the future. With approvals in multiple regions—including the United States, Japan, and several others—Leqembi represents a beacon of hope in the ongoing battle against Alzheimer’s disease.

In conclusion, the launch of Leqembi in the EU serves not just as a pivotal moment in drug development but also reflects the ongoing commitment to improving the lives of those impacted by Alzheimer's. Patients, families, and healthcare providers now possess a new tool in their arsenal against a relentless disease that has long demanded innovative solutions.