With New Trial Data, Lecanemab Wins FDA Breakthrough Status

With New Trial Data, Lecanemab Wins FDA Breakthrough Status

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With New Trial Data, Lecanemab Wins FDA Breakthrough Status

Based on new evidence from an ongoing Phase 2b clinical trial, the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to lecanemab, also called BAN2401, an investigational antibody for treating early Alzheimer’s disease. The therapy, being developed jointly by Eisai and Biogen, is designed to slow Alzheimer’s progression. The FDA’s decision was based on clinical evidence from Study 201, a Phase 2b (NCT01767311) trial that enrolled patients who had mild cognitive impairment or dementia…

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