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Based on pre-specified analysis showing consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses.
July 20, 2021
By: Kristin Brooks
Managing Editor, Contract Pharma
Eisai Co., Ltd. and Biogen’s lecanemab (BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of Alzheimer’s disease (AD), was granted Breakthrough Therapy designation from the FDA. Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. The benefits of a Breakthrough Therapy designation includes more guidance on the development program and eligibi...
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