Leqembi® Receives Approval for IV Maintenance Treatment in China

Leqembi® Approved for IV Maintenance Treatment in China

In a notable step forward for Alzheimer’s disease treatment, BioArctic AB’s partner, Eisai, has announced that lecanemab, marketed as Leqembi, has received approval from China’s National Medical Products Administration (NMPA) for intravenous (IV) maintenance dosing. This new treatment modality, which allows for administration once every four weeks, follows an initial regimen established early in the treatment process.

The journey of lecanemab's approval in China began in January 2024 when it was officially authorized for treating patients with mild cognitive impairment (MCI) or the early stages of Alzheimer's disease. This targeted initiative aims to address the pressing needs of those facing early dementia signs and to provide a consistent therapeutic option for sustaining cognitive health.

Eisai and BioArctic have worked collaboratively to develop this innovative treatment which addresses Alzheimer’s disease on multiple fronts. Alzheimer’s, characterized by the accumulation of amyloid-beta plaques and neurofibrillary tangles within the brain, represents a formidable challenge in neurology. This progressive illness is marked by severe cognitive decline, making prompt and efficacious therapeutic solutions paramount.

Lecanemab’s unique mechanism allows it to confront the disease by simultaneously targeting both soluble (protofibrils) and insoluble forms of amyloid-beta. The treatment is designed to combat neurodegeneration, aiming to mitigate the impact of tau pathology as well. By taking a dual-targeting approach, lecanemab aims to slow the progression of Alzheimer's and improve the overall quality of life for patients.

The decision to implement a maintenance dosing protocol of 10 mg/kg every four weeks, following an 18-month initiation phase where patients receive 10 mg/kg biweekly, illustrates a shift toward more manageable treatment regimens for patients and healthcare providers alike. This adjustment reflects a broader trend within Alzheimer’s care aimed at sustaining therapeutic benefits with less frequent dosing, which could enhance patient adherence and comfort.

The collaborative efforts in the research and development of lecanemab trace back to BioArctic's longstanding partnership with Eisai, initiated in 2005. The partnership has yielded significant advancements in the fight against neurodegenerative diseases, with BioArctic contributing key discoveries such as the identification of the Arctic mutation, which has propelled the development of lecanemab. As part of this collaboration, Eisai takes charge of clinical development and commercialization processes, ensuring that lecanemab reaches the patients who need it most.

In terms of global presence, lecanemab has gained approval in several countries, including the United States, Japan, and across the European Union, for use in patients at the early stages of Alzheimer’s disease. Furthermore, it is undergoing regulatory reviews in various territories, enhancing its potential reach and impact.

While the fight against Alzheimer’s is ongoing, the approval of lecanemab in China symbolizes a beacon of hope not only for patients but also for families affected by the disease. Studies continue to explore the full potential of lecanemab, with future investigations such as the AHEAD 3-45 initiative focusing on preclinical Alzheimer’s and examining its long-term benefits and applications.

As the landscape of Alzheimer’s treatment evolves, innovations such as lecanemab’s maintenance therapy are paving the way for more effective management of this debilitating condition. Both Eisai and BioArctic remain committed to enhancing the lives of individuals battling Alzheimer’s disease, aiming to turn a new page in the narrative of Alzheimer’s care.

For further inquiries, please contact:

Oskar Bosson,
Vice President, Communications and Investor Relations,
BioArctic AB
Email: [email protected]
Tel: +46 70 410 71 80

About BioArctic AB

BioArctic AB is a Swedish biopharmaceutical research company dedicated to developing innovative treatments aimed at halting or slowing the progression of neurodegenerative diseases. Their flagship product, Leqembi, represents a major milestone in Alzheimer's treatment, and they continue to advance their research portfolio with potential treatments for other neurodegenerative conditions.