Eisai has submitted a marketing authorization application to the Pharmaceuticals and Medical Devices Agency (PMDA) for investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab for early Alzheimer’s Disease (AD) in Japan.
Lecanemab is intended for the treatment of mild cognitive impairment (MCI) due to AD and mild AD dementia with confirmed amyloid pathology presence in the brain.
The application is based on the data obtained from the Phase III Clarity AD trial and Phase IIb Study 201 trial, in which treatment with lecanemab showed a clinical decline reduction in early AD.
Before the application submission, Eisai used PMDA’s prior assessment consultation system to reduce the review period for the therapy.
Lecanemab treatment resulted in statistically significant results in the Clarity AD study.
All important secondary endpoints also demonstrated highly statistically significant data.
Starting at three months, lecanemab treatment showed a statistically significant reduction in amyloid plaque burden in specific at all timepoints, in the amyloid PET study.
It also statistically slowed decline of activities of daily living on ADCS MCI-ADL3 significantly.
Infusion reactions, ARIA-H, ARIA-E (edema/effusion), headache, and fall were the most common adverse events (>10%) observed in the lecanemab group.
In January this year, the US Food and Drug Administration (FDA) granted accelerated approval to lecanemab as a treatment for AD.
Last month, Eisai initiated data submission for BLA to the National Medical Products Administration (NMPA) of China.
The company serves as the lead of lecanemab development and regulatory submissions across the globe.
Eisai and Biogen agreed to co-commercialise and co-promote the product.