BioArctic Partner Eisai Reports P-III (Clarity AD) Study Results of Lecanemab for the Treatment of Alzheimer's Disease
Shots:
- The P-III confirmatory (Clarity AD) study evaluates lecanemab (10mg/kg, BIW) in a ratio (1:1) in 1795 patients with early AD
- The trial met the 1EPs & 2EPs i.e., reduction in clinical decline on the global cognitive & functional scale, 27% in CDR-SB @18mos. in the ITT population, significant changes in CDR-SB from baseline as early as 6mos. The 2EPs showed a significant result, a change from baseline at 18mos. in amyloid levels in the brain measured by amyloid PET, ADAS-cog 14, ADCOMS & the ADCS MCI-ADL
- The total incidence of ARIA (ARIA-E & ARIA-H) was 21.3% vs 9.3%. Eisai plans to discuss the results with regulatory authorities in the US, Japan & EU with an expected filing for traditional approval in the US & MAA in Japan and the EU at the end of Q1’23
Ref: PR Newswire | Image: BioArctic
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