FDA expands approval of Exelon Patch (Novartis) to severe Alzheimers Disease

The FDA has expanded the approved indication for Exelon Patch (rivastigmine transdermal system), from Novartis, to include the treatment of people with severe Alzheimer's disease (AD). Exelon Patch is now the first and only transdermal therapy approved to treat patients with mild, moderate and severe AD.

Approval was based on the pivotal ACTION study, a randomized, double-blind study, in which the Exelon Patch 13.3 mg/24h demonstrated statistically significant improvement in overall cognition and function in severe AD patients versus the 4.6 mg/24h dose at week 24, as assessed by measures of cognition and daily function. These data support the efficacy of Exelon Patch 13.3 mg/24h in this advanced population of patients suffering from AD. The most commonly observed adverse reactions included application site erythema.