(RTTNews.com) - Novartis Pharmaceuticals Corp., an affiliate of Swiss drug giant Novartis AG ( NVS ), announced Friday that the US Food and Drug Administration has expanded the approved indication for Exelon Patch to include the treatment of people with severe Alzheimer's disease. The approval is based on high dose Exelon Patch 13.3 mg/24h for severe Alzheimer's.
"This approval is a significant milestone in the treatment of Alzheimer's disease. It exemplifies Novartis' continuing commitment to the Alzheimer's community. 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," said Andre Wyss, President of Novartis Pharmaceuticals Corp.
A 24-week study showed statistically significant improvement in overall cognition and function compared to 4.6 mg/24h dose for people with severe Alzheimer's. These data support the efficacy of Exelon Patch 13.3 mg/24h in this advanced population of patients suffering from Alzheimer's.
Earlier in September 2012, Exelon Patch was approved for treatment of mild to moderate memory problems or dementia, of the Alzheimer's type and mild to moderate dementia associated with Parkinson's disease.
"Millions of patients currently suffer from Alzheimer's, a debilitating and heartbreaking disease marked by a decline in overall cognition and function. While there is currently no cure, there is help for patients along the journey, and new treatment options play an important role," said John Schall, CEO, Caregiver Action Network.
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.
Exelon Patch, or rivastigmine transdermal system, is now the first and only transdermal therapy approved to treat patients with mild, moderate and severe Alzheimer's.
Alzheimer's disease is the sixth-leading cause of death. More than five million Americans are living with Alzheimer's, a progressive disease with limited treatment options. An estimated 5.2 million Americans of all ages have Alzheimer's disease in 2013, according to data from the Alzheimer's Association.
In Friday's regular trading session, NVS is currently trading at $70.83, up $0.41 or 0.58% on a volume of 1.35 million shares.
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