Posted by Michael Wonder on 06 Mar 2022
Eisai initiates submission of application data under the prior assessment consultation system in Japan with the aim of obtaining early approval for investigational anti-amyloid beta protofibril antibody lecanemab
4 March 2022 - Eisai and Biogen announced today that Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency of application data under the prior assessment consultation system in Japan for the investigational anti-amyloid beta protofibril antibody lecanemab.
The lecanemab Clarity AD Phase 3 clinical trial for mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer's disease (collectively known as early Alzheimer's disease) is on-going.
