Posted by Michael Wonder on 10 May 2022
Eisai completes rolling submission to the U.S. FDA for biologics license application of lecanemab for early Alzheimer's disease under the accelerated approval pathway
10 May 2022 - Eisai and Biogen announced today that Eisai has completed the rolling submission to the U.S. FDA of a biologics license application under the accelerated approval pathway for the investigational anti-amyloid beta protofibril antibody lecanemab for the treatment of mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer's disease (collectively known as early Alzheimer's disease) with confirmed presence of amyloid pathology in the brain.
As part of the completed rolling submission, Eisai has requested priority review.
