Eisai and Biogen Inc. announced that the U.S. FDA granted Lecanemab (BAN2401) Breakthrough Therapy Designation – QNT Press Release

An anti-amyloid Beta Protofibril antibody for the treatment of Alzheimer’s disease

Tokyo, June 24, 2021-(JCN News Line)-Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted lecanemab (BAN2401) breakthrough therapy designation, a Investigational anti-amyloid beta (Abeta) fibril antibody for the treatment of Alzheimer’s disease (AD).

Breakthrough Therapy Designation is an FDA program designed to accelerate the development and review of drugs for serious or life-threatening diseases. The benefits of breakthrough therapy designation include more in-depth guidance on effective development plans and eligibility for rolling reviews and potential priority reviews.


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