Biogen and Eisai's Alzheimer's Drug Leqembi Receives FDA Accelerated Approval

Zhitong Finance APP learned on Friday that the FDA granted accelerated approval to Leqembi (lecanemab), jointly developed by Eisai and Biogen (BIIB.US), for the treatment of Alzheimer's disease (AD). Leqembi is the second innovative Alzheimer's disease therapy targeting β-amyloid in recent years, and this approval also represents another significant advancement in the field of Alzheimer’s disease treatment. During Friday's trading session, Biogen’s stock price surged over 7% at one point. By the close, the stock had pulled back to a gain of 2.82%.

Targeting amyloid protein is one of the important directions for the development of new drugs for Alzheimer's disease. Leqembi is an anti-beta-amyloid protein (Aβ) antibody that can bind to soluble Aβ aggregates and promote their clearance. It has the potential to alter disease pathology and slow disease progression. The FDA has granted this therapy Fast Track designation, Priority Review status, and Breakthrough Therapy designation.

At the Alzheimer's Clinical Trials Conference held at the end of 2022, Eisai and Biogen presented the Phase 3 clinical trial data for Leqembi. Compared to placebo, Leqembi reduced the rate of increase in the comprehensive CDR-SB score, which evaluates patients' cognition and daily function, by 27% after 18 months (a higher CDR-SB score indicates lower clinical function), and decreased amyloid plaque levels by approximately 70% over 18 months.