New Alzheimer's drug can slow the progression of Alzheimer's disease, but regulators will weigh its relatively modest efficacy against safety risks
The drug slowed cognitive decline in patients in the early stages of the disease by 27% over 18 months.
14% of patients taking lecanemab experienced "serious adverse events," compared to 11.3% of those receiving a placebo. Deaths occurred in 0.7% of the patients receiving lecanemab and in 0.8% of those in the placebo group, per the study. None of the deaths were considered related to lecanemab.by Science and STAT occurred after the 18-month randomized study period, per the NYT. Both patients received lecanemab in an extension study after the 18 months ended. The company told STAT that the two deaths represent the only fatal macro-hemorrhages among patients who have received lecanemab in clinical trials.
of the class of Alzheimer's drugs to which lecanemab belongs to patients enrolled in clinical trials or CMS-approved comparative studies. The agency has said it would modify its position and cover costs for a wider population if evidence warrants a shift.
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