The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion on the marketing authorisation of lecanemab (trade name Leqembi) from the pharmaceutical company Eisai for the treatment of cognitive impairment and mild dementia due to Alzheimer's disease.

Following the EMA's decision, the pharmaceutical company Eisai GmbH can request a new evaluation within 15 days of receiving the opinion. It is also expected that it will provide new information on the progress of patients treated with the drug in the countries where it is available.

According to a statement from the EMA, the evaluation committee has considered that The benefits observed in the treatment for cognitive impairment are not sufficiently relevant to accept the risks associated with its side effectsIn particular, they highlighted the frequent occurrence of amyloid-related imaging abnormalities, involving swelling and possible bleeding in the brains of patients who received Leqembi. Overall, the CHMP considered that the benefits of the treatment are not large enough to outweigh the risks associated with Leqembi.

In July 2023 the drug was approved by the FDA (US Food and Drug Administration), and was The first approved through the traditional route of the US regulatory agency that intervenes in the progression of the diseaseIt has also been approved by regulatory authorities in China, Hong Kong, Israel, Japan and South Korea.