The North American regulatory agency FDA (U.S. Food and Drug Administration) has given the green light to the commercialisation in the United States of lecanemab (with the commercial name of Leqembi), an antibody for the treatment of cognitive impairment and mild dementia due to the disease of Alzheimer's. The drug, developed and marketed by the pharmaceutical companies Biogen and Eisai, is the first approved by FDA through the traditional route to intervene in the progression of the disease.
“This is a hopeful announcement for people who suffer from the disease and their families,” says 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”, he declares.
Results from the phase III study of the drug were presented by Biogen and Eisai at the Alzheimer's Clinical Trials Conference (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 slowed cognitive decline by 27% in patients in the early stages of Alzheimer's. It is therefore the first drug that would be able to modify the course of the disease, slowing down cognitive deterioration, which is why it represents a significant advance in Alzheimer's research.
Following the presentation of these results, last June, a panel of six FDA experts voted unanimously that lecanemab showed clinical benefit for the treatment of the disease. In this way, the door was opened for its definitive approval, via traditional approval, for its commercialisation in the United States. A few months earlier, the drug had already received approval for its commercialisation in the country through the accelerated approval system, which allows the approval of drugs for serious diseases and that respond to an uncovered medical demand while researchers continue to study the drug to verify and describe its clinical benefit.
To know the situation of the drug in Europe, we will have to wait for the results of the application for drug approval by the European Medicines Agency. "There are still many steps to take before this drug can become a therapy in our country, but this is good news," says Dr. Navarro.