FDA expands approval of Novartis' Exelon Patch to include severe Alzheimer's disease

Swiss drug major Novartis (NOVN: VX) says that the US Food and Drug Administration has broadened the label of its Exelon Patch (rivastigmine transdermal system) to include severe Alzheimer's disease. For the 12 months ended January 31, 2013, in its current indications, Exelon had total US sales of around $521 million, according to IMS Health data.

The decision was based on results from the ACTION trial, which showed that the high-dose Exelon Patch led to a statistically significant improvement in overall cognition and function after 24 weeks, compared with a lower-dose version of the patch, for people with severe Alzheimer's disease.

The patch first gained FDA approval in 2007 for the treatment of mild-to-moderate memory problems or dementia of the Alzheimer's type, and for mild-to-moderate dementia associated with Parkinson's disease, and for the high dose of the product in 2012. The company said the new approval makes Exelon the only transdermal therapy approved to treat all stages of Alzheimer’s disease.