MB, I think we can now safely assume that the Amyloid-Beta hypothesis has now been proved, we can argue over clinical benefit, cost, safety profile but I am certain the industry will be able to improve in all of these areas over the coming years .... I also suspect when the data is released, we will actually see even meaningfully better results in certain subgroups.
As a quick review
Primary endpoint: Lecanemab reduced clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo at 18 months by 27%, representing a treatment difference in the score change of -0.45 (p=0.00005).
Key secondary endpoints: All key secondary endpoints were also met with highly statistically significant results compared with placebo (p<0.01). Key secondary endpoints were the change from baseline at 18 months compared with placebo of treatment in amyloid levels in the brain measured by amyloid positron emission tomography (PET), the AD Assessment Scale-cognitive subscale14 (ADAS-cog14), AD Composite Score (ADCOMS) and the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL).
Adverse events: The incidence of amyloid-related imaging abnormalities-edema/effusion (ARIA-E) was 12.5% in the lecanemab group and 1.7% in the placebo group. The ARIA-H (ARIA cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis) rate was 17.0% in the lecanemab group and 8.7% in the placebo group.
Given the FDA rolling submission from the Phase II data we will likely see an accelerated approval the current PUDFA data is 6th January 2023
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