Revolutionary Treatment for Early Alzheimer’s Disease in Japan: Eisai Submits Application for Lecanemab Marketing Authorization

Eisai Co., Ltd. and Biogen Inc. have made a groundbreaking announcement today: they have jointly submitted a marketing authorization application for lecanemab, a revolutionary anti-amyloid beta protofibril antibody. If approved, the groundbreaking treatment will be used to treat mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s dementia (collectively known as early Alzheimer’s) with confirmed presence of amyloid pathology in the brain. The application was submitted to the Pharmaceuticals and Medical Devices Agency (PMDA).

Eisai used the prior assessment consultation system of PMDA to shorten the review period for lecanemab, prior to submitting this application. The results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201) demonstrated that this lecanemab treatment could significantly reduce clinical decline in early Alzheimer’s disease. With this application, Eisai seeks to bring lecanemab to those who need it most.

Lecanemab treatment proved successful in reducing clinical decline on the global cognitive and functional scale, as demonstrated by its primary endpoint (CDR-SB2: Clinical Dementia Rating-Sum of Boxes) as early as six months, and was further supported by key secondary endpoints. Notably, treatment with lecanemab resulted in a noticeable reduction in amyloid plaque burden, starting at 3 months in the amyloid PET study, and a slowed decline of activities of daily living on ADCS MCI-ADL3. While the most common adverse events experienced were infusion reactions, ARIA-H, ARIA-E, headache, and fall, the remarkable results of lecanemab treatment make it a promising option for those looking to slow the progression of dementia.

At the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference in November 2022, the groundbreaking results of the Clarity AD study were unveiled and simultaneously published in the prestigious New England Journal of Medicine. This study brings us one step closer to understanding and treating Alzheimer’s disease.

On January 6, 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lecanemab as a treatment for AD, and Eisai submitted a Supplemental Biologics License Application (sBLA) for traditional approval. Just three days later, Eisai submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA). Additionally, as of December 2022, Eisai has been in the process of submitting data for BLA to the National Medical Products Administration (NMPA) of China.

Eisai takes the lead in the development and regulatory submissions of lecanemab, collaborating with Biogen to co-commercialize and co-promote the product. As the final decision-maker, Eisai ensures the success of this groundbreaking medicine.

This new agent is currently being investigated for potential therapeutic uses. Although there is no guarantee of its eventual approval by health authorities, the results of this investigation could lead to exciting new treatments for various conditions. Stay tuned to find out more about the potential of this investigational agent!

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