The U.S. Food and Drug Administration has granted fast track approval for the Alzheimer’s drug Lecanemab, marking it as one of the first experimental dementia drugs that appears to slow cognitive decline. Dr. Billy Dunn, director of the Office of Neuroscience at the FDA's Center for Drug Evaluation and Research, stated that “Alzheimer’s disrupts the lives of those affected immeasurably and has devastating effects on their loved ones.” He added, “This treatment option is the latest to target the underlying disease process of Alzheimer’s and affect it rather than just treating the symptoms of the disease.”
According to an FDA statement, the drug "Lecanemab" will be marketed under the name Leqembi. The statement noted that the drug has shown "potential as a treatment for Alzheimer’s by slowing the progression of the disease, according to phase 3 trial results," but has raised safety concerns due to its association with some serious events, including brain swelling and bleeding.
In July, the FDA accepted the request from Eisai to introduce "Lecanemab" through the accelerated approval pathway, which allows for early approval of drugs that address serious conditions and “fill unmet medical needs” while further studies continue in larger and longer trials. If these trials confirm that the drug provides clinical benefit, the FDA may grant traditional approval. However, if the confirmatory trial fails to show benefit, the FDA has regulatory procedures that could lead to the withdrawal of the drug from the market.
