Reacción a "EMA recommends not approving donanemab for Alzheimer's"

The European Medicines Agency CHMP's negative opinion on donanemab is based on the assessment that its benefits do not outweigh the risks, in particular due to one of the associated adverse effects, ARIA [amyloid-related imaging abnormalities]. Specifically, ARIA occurred in 36.8% of patients treated with donanemab, compared to 14.9% of those receiving placebo. Although most cases were asymptomatic, 1.6% of treated patients experienced severe ARIA events, with fatal outcomes in three cases. In addition, the CHMP has not accepted the proposal to restrict use of the drug to patients who do not carry the APOE ε4 allele, who have a lower risk of ARIA.

This decision contrasts with the previous approval of the drug in the US, UK, China and Japan, where the same clinical data were considered, as well as with the previous positive CHMP opinion on lecanemab, another anti-amyloid treatment. Given the precedent of lecanemab, which initially received a negative opinion but was later approved, it is possible that the decision on donanemab will be re-evaluated. The company's request for review opens the door to future discussions on the availability of this therapy in Europe.