Posted by Michael Wonder on 24 Jun 2021
Eisai and Biogen announce U.S. FDA grants breakthrough therapy designation for lecanemab (BAN2401), an anti-amyloid beta antibody for the treatment of Alzheimer's disease
24 June 2021 - Eisai and Biogen today announced that the U.S. FDA has granted breakthrough therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta protofibril antibody for the treatment of Alzheimer’s disease.
The FDA’s breakthrough therapy designation for lecanemab is based on the recently published results of a Phase 2b clinical trial (Study 201) of 856 patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease with confirmed presence of amyloid pathology.
