The European Commission announced on Wednesday that it has officially approved a treatment designed to slow cognitive decline in certain patients with Alzheimer’s disease, following an endorsement from the European Medicines Agency (EMA).
The authorization for this treatment, marketed under the name Leqembi, was granted on Tuesday and is based on the EMA’s scientific assessment, which determined that the benefits of the drug outweigh its risks, as emphasized in a statement by the Commission.
At the end of 2024, the European regulator recommended granting market approval for Leqembi (lecanemab) for “the treatment of mild cognitive impairment (memory and thinking disorders) or mild dementia due to Alzheimer’s disease (early-stage Alzheimer’s disease).”
It is important to note that this approval applies only to patients who are at a lower risk of potential brain hemorrhage, specifically those with “one or no copies of the ApoE4 gene,” which is recognized as a significant risk factor for Alzheimer’s disease.
Leqembi, developed by the Japanese pharmaceutical company Eisai and the American manufacturer Biogen, received approval in January 2023 in the United States for patients who have not progressed to an advanced stage of the disease. It is also available in Japan and China.
Despite decades of research, scientists have yet to achieve a true breakthrough in the battle against Alzheimer’s disease, which impacts tens of millions of individuals worldwide.
