Washington, USA (CNN) — The US Food and Drug Administration (FDA) granted accelerated approval Friday for the Alzheimer’s drug lecanemab, one of the first experimental dementia drugs that appears to slow cognitive decline.
“Alzheimer’s disease immeasurably disrupts the lives of those who suffer from it and has devastating effects on their loved ones,” said Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, in a statement.
“This treatment option is the latest treatment to target and influence the underlying disease process of Alzheimer’s disease, rather than just treating the symptoms of the disease,” he added.
According to the US Food and Drug Administration’s statement, 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 the results of the Phase 3 trial, but has 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 application to place licanimab under the accelerated approval pathway, 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, longer trials.
If these trials confirm that the drug provides clinical benefit, the FDA can grant conventional approval. But if a confirmatory trial doesn’t show a benefit, the FDA has the regulatory actions that might lead to the drug being pulled off the market.
