The European Medicines Agency has rejected a marketing authorisation request for the Alzheimer’s disease drug lecanemab, stating that the drug’s small effect in delaying cognitive decline “does not counterbalance the risk of serious adverse events.”1
The EMA highlighted trial data showing that after 18 months of treatment the dementia rating score of patients taking lecanemab (which is marketed as Leqembi) increased by an average of 1.21, against a 1.66 increase in patients taking placebo—a difference it described as “small.”
The agency highlighted the “frequent occurrence” of amyloid related imaging abnormalities (ARIA), a side effect involving swelling and potential bleedings in the brain, in the treatment group. “The seriousness of this side effect should be considered in the context of the small effect seen with the medicine,” it said.
The drug’s manufacturer, Eisai, has appealed the decision, meaning the authorisation request will be re-examined within 15 days of receiving the opinion (25 July). Lynn Kramer, Eisai’s chief …
