The risk of serious side effects from the antibody is higher than the expected positive effect, the EMA announced in Amsterdam on Friday. The authority referred in particular to possible water retention and bleeding in the brain of people being treated with the drug.
Lecanemab – trade name Leqembi – has been available in the USA since the beginning of 2023 for the treatment of early-stage Alzheimer’s disease. Although the therapy does not improve symptoms, it can slow the progression of the disease somewhat at this stage. The antibody would therefore only be suitable for a very limited group of Alzheimer’s patients, according to experts’ estimates for less than ten percent.
Disadvantages of the drug outweigh advantages according to the EU
Side effects include microbleeds and edema in the brain. Therefore, therapy must be monitored regularly with magnetic resonance imaging (MRI) scans. According to the authority, the responsible committee of the EMA decided “that the observed effect of the drug in slowing cognitive decline does not outweigh the risk of serious side effects (…)”.
The authority’s recommendation is necessary for the approval of medicines in the EU. According to the authority, the company Eisai, which submitted the application for approval for the EU, can request a new review within 15 days.
