Eisai and Biogen’s Leqembi (Lecanemab) Receives the NMPA’s Approval for the Treatment of Alzheimer’s Disease
Shots:
- The approval was based on the P-III (Clarity AD) trial evaluating the safety & efficacy of Leqembi (10mg/kg, Q2W, IV) vs PBO in patients (n=1,795), randomized in a ratio 1:1, with early AD at 235 sites across North America, Europe & Asia. The 1EP of the study includes change in CDR-SB at 18mos., global cognitive & functional scale & 2EPs includes change in amyloid PET at 18mos.
- The results showed a 1.21 vs 1.66 change in CDR-SB with a clinical decline on the global cognitive & functional scale along with a mean change in the PET sub-study of -55.5 vs 3.6
- Leqembi is a humanized anti-soluble aggregated Aβ mAb that selectively binds to Aβ plaque components, reducing Aβ protofibrils & plaques in the brain
Ref: EISAI | Image: EISAI
Related News:- Eisai to Launch Leqembi (Lecanemab) in Japan for the Treatment of Alzheimer’s Disease (AD)
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
