BioArctic Partner Eisai Reports MAA Submission of Leqembi (lecanemab) to the EMA for Early Alzheimer's Disease
Shots:
- The application was based on the P-III study (Clarity AD) & P-IIb study evaluating lecanemab vs PBO in 856 & 1795 patients
- The study (Clarity AD) met its 1EPs & 2EPs i.e., 27% reduction in clinical decline on the global cognitive and 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%)
- In the P-IIb study, reduction in PET SUVR which 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. Lecanemab's MAA intends to submit in Japan in Q1’23
Ref: PRNewswire | Image: BioArctic
Related News:- Eisai and Biogen Receive the US FDA’s Accelerated Approval of Leqembi (lecanemab-irmb) for Alzheimer's Disease
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