The European Medicines Agency (EMA) has accepted for review Eisai and Biogen’s marketing authorization application (MAA) submitted for lecanemab to treat early Alzheimer’s disease (AD).
Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody intended to treat AD with confirmed amyloid pathology.
On 6 January, it received accelerated approval from the US Food and Drug Administration (FDA) as a treatment for AD.
Eisai submitted a Supplemental Biologics License Application (sBLA) on the same day for obtaining the FDA approval under the traditional pathway based on the Phase III Clarity AD confirmatory trial results.
This trial of lecanemab met its primary and all key secondary endpoints with statistically significant results.
The company submitted a MAA in Japan to the Pharmaceuticals and Medical Devices Agency (PMDA) during this month.
In China, a submission has been initiated to the National Medical Products Administration (NMPA) in December last year on data for a BLA.
Eisai will be responsible for the development and regulatory submissions of lecanemab across the globe.
Eisai and Biogen will co-commercialise and co-promote the product and the former will have final decision-making authority.
Lecanemab, which is the result of a strategic research partnership between Eisai and BioArctic, is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody that is directed against aggregated soluble (protofibril) and insoluble Aβ forms.
It attaches and eliminates Aβ protofibrils selectively. They are thought to contribute to AD neurotoxicity and may have the potential to have an effect on disease pathology.
Additionally, it can slow down the disease progression.