The agency cites the results of larger clinical trials, recently published in a scientific journal. Conducted on nearly 1,800 people followed up for 18 months, they revealed a 27% reduction in cognitive decline in patients treated with lecanemab. But the study also revealed serious side effects: some of the treated patients suffered from brain hemorrhages.
Additionally, at least one person who received the treatment has died. The FDA has included a warning about the risk of bleeding in the drug information. It is the second Alzheimer’s treatment recently approved by the FDA, following Aduhelm in 2021.
