The American regulatory agency FDA (US Food and Drug Administration) has given the green light to the marketing in the United States of lecanemab (under the trade name Leqembi), an antibody for the treatment of cognitive impairment and mild dementia due to Alzheimer's disease. The drug, developed and marketed by the pharmaceutical companies Biogen and Eisai, It is the first drug approved through the traditional FDA route that intervenes in the progression of the disease.
“It is a hopeful announcement for people suffering from the disease and their families,” ensures the Dr. Arcadi Navarro, director of the Barcelonaβeta Brain Research Center and the Pasqual Maragall Foundation. “This and other advances show us that we are in a new era in the approach to research and treatment of the disease,” declares.
Modifiable factors are those that concern the control of cardiovascular health and the promotion of healthy lifestyle habits, among which the most notable are cognitive and social activity, adequate nutrition, physical activity and ensuring good quality sleep. Phase III study results The drug's data were presented by Biogen and Eisai at the Clinical Trials Conference on Alzheimer's (CTAD) last November in San Francisco and published in The New England Journal of Medicine. According to the article, lecanemab reduces amyloid markers and has managed to slow down cognitive decline by 27% in patients in the early stages of Alzheimer's. This is the first drug that could modify the course of the disease, slowing cognitive decline, and therefore represents a significant advance in Alzheimer's research.
Following the presentation of these results last June, a panel of six FDA experts voted unanimously to approve lecanemab showed clinical benefit for the treatment of the disease. In this way, the door was opened to its final approval, through the traditional approval, for marketing in the United States. A few months earlier, the drug had already received approval for marketing in the country through the accelerated approval, which allows for the approval of drugs for serious diseases that respond to an unmet medical demand while researchers continue to study the drug to verify and describe its clinical benefit.
To find out the status of the drug in Europe, we will have to wait for the results of the application for approval of the drug by the European Medicines Agency (EMA). “There are still many steps to be taken before this drug can become a therapy in our country, but this is good news.”, assures the Dr. Navarro.
