The Center for Drug Evaluation (CDE) website indicates that Japan-based Eisai’s (TYO: 4523) lecanemab has been awarded priority review status. The drug falls under the category of “clinically urgent shortage drugs and innovative and modified drugs for the prevention and treatment of major infectious diseases and rare diseases.” This designation highlights the potential of lecanemab in addressing a significant unmet medical need.
Targeted Indication and Mechanism of Action
The targeted indication for lecanemab is early Alzheimer’s disease (AD), specifically AD-derived mild cognitive impairment (MCI) and mild AD dementia with a confirmed pathology of amyloid protein. Lecanemab is a humanized monoclonal antibody designed to selectively bind and eliminate soluble and toxic β-amyloid protein (Aβ) aggregates (fibrils), which are believed to play a crucial role in the process of AD nerve degeneration.
Clinical Trial Results and Market Filings
Clinical trials have shown that compared to the placebo, lecanemab causes a dose-dependent, longitudinal, and significant reduction in β-amyloid accumulation. Eisai filed for market approval for the drug in China in December 2022. Following its approval for marketing in the US in January 2023, lecanemab is expected to see additional market filings in Japan and Europe by the end of Q1 2023. This global expansion underscores Eisai’s commitment to making lecanemab available to patients worldwide.-Fineline Info & Tech
