EMA issues negative opinion on marketing authorisation for lecanemab in Europe

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion on the marketing authorisation for 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 re-evaluation within 15 days of receiving the opinion. It is also expected that it will be able to provide new information on the progress of patients who are treated with the drug in countries where it is available.

According to a statement from the EMA, the evaluation committee considered that the effect observed in the drug to delay cognitive decline does not counteract the risk of serious side effects associated with the drug. In particular, they highlighted the frequent appearance of imaging abnormalities related to amyloid, involving swelling and possible bleeding in the brain of patients who received Leqembi. The CHMP has generally considered that the benefits of the treatment are not sufficiently large to outweigh the risks associated with Leqembi.

In July 2023, the drug was approved by the US Food and Drug Administration (FDA), the first to be approved by the traditional route of the North American regulatory agency that intervenes in the progression of the disease. In addition, it was also authorized by the regulatory authorities of China, Hong Kong, Israel, Japan and South Korea.