FDA approves Novartis' Exelon Patch for treatment of severe Alzheimer's disease

NovartisJun 28 2013

The US Food and Drug Administration (FDA) has expanded the approved indication for Exelon® Patch (rivastigmine transdermal system) to include the treatment of people with severe Alzheimer's disease (AD) with Exelon Patch 13.3mg/24h.  Exelon Patch is now the first and only transdermal therapy approved to treat patients with mild, moderate and severe AD.

"Millions of patients currently suffer from Alzheimer's, a debilitating and heartbreaking disease marked by a decline in overall cognition and function," said John Schall, CEO, Caregiver Action Network.  "While there is currently no cure, there is help for patients along the journey, and new treatment options play an important role."

The approval of Exelon Patch for severe AD was based on the pivotal ACTION (ACTivities of Daily Living and CognitION in Patients with Severe Dementia of the Alzheimer's Type) study.  In this randomized, double-blind study, 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 (SIB and ADCS-ADL-SIV), respectively. 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 (redness or rash), fall, insomnia, vomiting, diarrhea, weight loss and nausea.  These reactions were observed in a higher percentage of patients in the Exelon Patch 13.3 mg/24h dose than in the Exelon Patch 4.6 mg/24h dose.

"This approval is a significant milestone in the treatment of Alzheimer's disease.  It exemplifies Novartis' continuing commitment to the Alzheimer's community," said Andre Wyss, President of Novartis Pharmaceuticals Corporation. "With this expanded indication, Exelon Patch can now address a wider range of Alzheimer's patients, including the large population of people in the severe stage of the disease."

Alzheimer's is an irreversible degeneration of the brain that causes disruptions in memory, cognition, personality, and other functions and is the most common form of dementia among people age 65 and older. This disease affects not only patients but the millions of family members who have become caregivers for their loved ones.