The Peripheral and Central Nervous System Drug Advisory Committee of the Food and Drug Administration (FDA) issued a unanimous recommendation that the agency approve the investigational drug memantine for treatment of moderate to severe Alzheimer’s disease. Although advisory committee actions are not legally binding on the FDA, the agency often follows their recommendations. Final FDA action on memantine is expected by the end of 2003.
If approved, memantine would be the first drug given the green light for treatment of moderate to severe Alzheimer’s. The current mainstays of Alzheimer treatment, called cholinesterase inhibitors, are all approved for mild to moderate disease. In addition to being indicated for more advanced stages, memantine has a different mechanism of action than currently approved drugs.
(Source: The Alzheimer’s Association, online at www.alz.org)