Eisai/Biogen Alzheimer's Drug Lecanemab Receives Unanimous FDA Advisory Committee Support for Full Approval Based on Phase III CLARITY AD Data

On June 10, Eisai/Biogen jointly announced that at the FDA Peripheral and Central Nervous System Drugs Advisory Committee meeting, the expert panel voted 6:0 in support of the full approval of their jointly developed Alzheimer's disease (AD) antibody therapy Leqembi (lecanemab) based on the positive results of the Phase III CLARITY AD study. The FDUFA date is set for July 6, 2023.

Lecanemab is an anti-amyloid beta (Aβ) monoclonal antibody that selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Aβ) aggregates (protofibrils), which are considered to contribute to the neurodegenerative process in AD. It is the result of collaboration between Eisai and BioArctic, with Eisai and Biogen jointly responsible for the development and commercialization of the product for AD treatment.

Lecanemab Mechanism of Action (Source: Eisai Co., Ltd. Official Website)

In January 2023, Lecanemab received accelerated approval from the FDA for market release. Although the FDA is not obligated to follow the recommendations of its advisory panel, the unanimous voting result of this meeting indicates an increased likelihood of lecanemab receiving full approval. If lecanemab receives full approval, it will become the first new Alzheimer's disease (AD) therapy to gain full FDA approval in 20 years.

Drug development in the field of the central nervous system (CNS) is notoriously challenging. Among these challenges, Alzheimer's disease (AD) remains particularly difficult due to its unknown etiology, causing many pharmaceutical companies to fail in this area. However, behind this difficult path lies immense clinical demand, market value, and historic opportunity. In May 2023, Eli Lilly announced positive results from the Phase III study of its Aβ antibody donanemab for the treatment of AD, and it plans to submit an application for regulatory approval to the FDA in the second quarter of 2023. Currently, the most advanced candidates in the race within the AD field are lecanemab from Eisai/Biogen and donanemab from Eli Lilly. It is hoped that after their approval, they will truly address the unmet clinical needs of AD patients.

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