Eisai Reports MAA Submission of Leqembi (lecanemab) for Early Alzheimer's Disease in Japan
- The application was based on the P-III study (Clarity AD) & P-IIb study (Study 201) evaluating lecanemab vs PBO in 856 & 1795 patients
- The study (Clarity AD) showed a 27% reduction in clinical decline on the global cognitive & functional scale @18mos., changes in CDR-SB from baseline. In the 2EPs, amyloid PET, ADAS-Cog14, ADCOMS & ADCS MCI-ADL showed significant results, SAEs (14.0% vs 11.3%), TEAEs (88.9% vs 81.9%), drug withdrawal due to TEAEs (6.9% vs 2.9%) & the results were presented at CTAD & published in the NEJM
- In the P-IIb study, reduction in PET SUVR evaluated amyloid-β accumulation in the brain. ADCOMS, CDR-SB & ADAS-cog14 showed a dose-dependent reduction in clinical decline with suppression rates of 29.7%/26.5%/47.2% in the 10mg/kg, BW, respectively
Ref: PRNewswire | Image: Eisai
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