Washington, USA (CNN) – The US Food and Drug Administration (FDA) on Friday granted accelerated approval for the Alzheimer’s drug lecanemab, one of the first experimental dementia drugs that appears to slow cognitive decline.
“Alzheimer’s disease disrupts the lives of those who suffer from it immeasurably and has devastating effects on their loved ones,” Dr. Billy Dunn, director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research, said in a statement.
“This treatment option is the ultimate cure for targeting and influencing the underlying disease process of Alzheimer’s, rather than just treating the symptoms of the disease,” he added.
According to the release from the US Food and Drug Administration, the drug “Lecanimab” will be marketed under the name Leqembi. The statement added that the drug showed “potential as a treatment for Alzheimer’s disease by slowing the progression of the disease, according to Phase 3 study results, but raised safety concerns due to its association with some serious events.” including brain swelling and bleeding”.
Last July, the Food and Drug Administration accepted Eisai’s request to put licanib on the accelerated approval path, which allows for early approval of drugs that treat serious conditions and “fill a medical need” while the drugs continue to be studied in larger and longer studies.
If these studies confirm that the drug provides clinical benefit, the FDA can grant conventional approval. But if a confirmatory study doesn’t show a lead, the FDA has the regulatory actions that could lead to the drug being pulled from the market.
