Swiss pharmaceutical giant Novartis Pharma AG won FDA approval April 24 for its U.S. subsidiary, Novartis Pharmaceuticals Corporation, to market rivastigmine tartrate (Exelon) for the treatment of mild to moderately severe Alzheimer’s disease. The drug has been on the market for several years in 65 other countries and was issued an Approvable Letter by the FDA last May. European studies indicate that the drug has major advantages over other products in its class.

Rivastigmine’s much anticipated U.S. approval is based on data from almost 4,000 individuals worldwide, the largest patient base studied by the FDA in the approval of any medication for dementia.

Rivastigmine is a cholinesterase inhibitor, effectively blocking the action of both acetylcholinesterase and butyrylcholinesterase, two enzymes in the brain responsible for the breakdown of the neurotransmitter, acetylcholine. Rivastigmine is the first drug in its class to block both enzymes, which significantly increases its efficacy. In addition, it is specific to brain tissue, largely eliminating many of the side effects common to other cholinesterase inhibitors.

In patients with mild to moderately severe Alzheimer’s disease, rivastigmine shows significant benefits in activities of daily living, such as eating, dressing, and completing household chores. Patients also sometimes see a reduction in symptoms such as delusions and agitation.

In U.S. studies, rivastigmine also has been shown to improve cognitive function including memory, thinking, and speaking.

Rivastigmine is the first drug approved that provides benefits in all three major areas of concern in Alzheimer’s treatment—activities of daily living, behavioral symptoms and cognition. A separate study also showed that rivastigmine therapy in nursing home patients reduced the use of other psychotropic medications.