FDA grants full approval to Alzheimer's treatment

The U.S. Food and Drug Administration on Thursday announced that it had granted full approval to a novel Alzheimer's disease treatment, asserting that trials have verified clinical benefit.

"Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease. This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease," said acting director Teresa Buracchio of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research.

Esai Inc, which produces Leqembi, received the approval. The drug in question "works by reducing amyloid plaques that form in the brain, a defining pathophysiological feature of the disease," the FDA stated. Effectively, the drug works to slow the pace of cognitive decline in someone with Alzheimer's disease.

Leqembi, in January, was placed under the accelerated approval pathway, a preliminary approval process that allows for limited use pending final trials.

Ben Whedon is an editor and reporter for Just the News. Follow him on Twitter.