Responding to Media reports, Eisai Co., Ltd. clarified that its investigational Alzheimer's disease drug lecanemab is not associated with two deaths involving brain bleeding that occurred in an Alzheimer's disease treatment trial.
Earlier there were reports that two deaths occurred in the Alzheimer's disease treatment trial.
Eisai said, "The two cases on lecanemab occurred in the open-label extension study. Both cases had significant comorbidities and risk factors including anticoagulation contributing to macrohemorrhage or death. Therefore, it is Eisai's assessment that the deaths cannot be attributed to lecanemab."
Eisai is developing the drug lecanemab with Biogen Inc. (BIIB).
Eisai presented full results of lecanemab phase 3 confirmatory clarity Alzheimer's disease study for early alzheimer's disease at clinical trials on alzheimer's disease conference.
Eisai's Clarity Alzheimer's disease or AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD (lecanemab group: 898 placebo group: 897) at 235 sites in North America, Europe, and Asia.
The participants were randomized 1:1 to receive either placebo or lecanemab 10-mg/kg IV biweekly, and the randomization was stratified according to clinical subgroup , presence or abs.
According to the company, mean change of CDR-SB from baseline at 18 months as the primary endpoint was 1.21 and 1.66 for lecanemab and placebo groups, respectively. Lecanemab treatment resulted in highly statistically significant results, reducing clinical decline on the global cognitive and functional scale, compared with placebo at 18 months by -0.45, representing a 27% slowing of decline.
All key secondary endpoints also showed highly statistically significant results compared with placebo.
During the study period, deaths occurred in 0.7% and 0.8% of participants in the lecanemab and placebo groups, respectively and no deaths were related to lecanemab or occurred with amyloid-related imaging abnormalities (ARIA) in 18-month double-blind study period. Serious adverse events were experienced by 14.0% of participants in the lecanemab group and 11.3% of participants in the placebo group.
Treatment-emergent adverse events occurred in 88.9% and 81.9% of participants in the lecanemab and placebo groups, respectively. Treatment-emergent adverse events leading to drug withdrawal occurred in 6.9% and 2.9% of participants in the lecanemab and placebo groups, respectively.
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