A Potential Breakthrough: Eisai Submits Marketing Authorization Application for Innovative Treatment of Early Alzheimer’s Disease in Japan!

BioArctic AB’s partner, Eisai, has recently submitted a marketing authorization application for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril[1] antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia (collectively known as early AD) with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency (PMDA). With the acceptance of the file by PMDA, BioArctic is entitled to a milestone of MEUR 5 — potentially representing a major breakthrough in the treatment of early Alzheimer’s disease.

Eisai has taken the necessary steps to bring lecanemab to market, having utilized the prior assessment consultation system of PMDA for the purpose of expediting the review period. Results from the Phase 3 Clarity AD study and Phase 2b clinical study have shown that lecanemab is effective in reducing clinical decline amongst those with early stage Alzheimer’s Disease. With this data, Eisai is now ready to submit their application to the PMDA in hopes of gaining approval and bringing lecanemab to market.

Lecanemab treatment has shown highly statistically significant results in reducing clinical decline of the global cognitive and functional scale, as well as key secondary endpoints. From as early as three months, amyloid plaque burden was significantly reduced, and activities of daily living were slowed. Common adverse events included infusion reactions, ARIA-H, ARIA-E, headache, and fall. With these impressive results, lecanemab is a promising treatment for dementia and Alzheimer’s Disease.

At the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference, the groundbreaking results of the Clarity AD study were presented to the world. Simultaneously, the results were published in the prestigious New England Journal of Medicine, offering a major breakthrough in the fight against Alzheimer’s disease.

On January 6, 2023, the U.S. Food and Drug Administration (FDA) granted lecanemab accelerated approval as a treatment for AD. On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for full approval under the traditional pathway. Subsequently, Eisai submitted its marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023. To complete the global rollout, Eisai initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China in December 2022.

Eisai and Biogen are collaborating to bring lecanemab to the world, with Eisai having the lead in global development and regulatory submissions, as well as final decision-making authority. Meanwhile, BioArctic is preparing to commercialize lecanemab in the Nordic, with no development costs and payments associated with regulatory filings, approvals, and sales milestones, plus royalties on global sales. On January 6, 2023, lecanemab was granted accelerated approval by the FDA in the US, and Eisai submitted an sBLA for full approval on the same day, followed by a MAA submission to the EMA on January 9. In China, Eisai has initiated submission of data for a BLA to the NMPA in December 2022.

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