Novartis AG receives first worldwide approval in US for Alzheimer''s patch

09 July 2007

Swiss drug maker Novartis AG (NVS), which has a special focus on neuroscience, today announced that its Exelon patch rivastigmine transdermal system, which can be applied to the back, chest or upper arm of the body, has been granted the first worldwide approval in the US as an effective medication for mild to moderate Alzheimer''s disease patients as an alternative to oral medication.

Novartis says that the once-daily skin patch could assure delivery of drug over 24 hours and maintains steady drug levels in the bloodstream. It helps improve tolerability in a higher proportion of patients receiving the therapeutic doses compared to the oral form of the medication. Unlike with the oral form of drug that may cause gastrointestinal side effects, the Exelon patch ensures that the medication has been administered with minimized side effects.

Novartis says that during trials, there were three times fewer reports of nausea and vomiting than with the capsule form of the drug and said that in trials of 1,200 patients, Exelon patch showed similar efficacy to the highest doses of Exelon capsules. The recommended dose was well tolerated in the trial, it added.

Novartis said Exelon is the first and only transdermal treatment for Alzheimer''s. The placebo controlled clinical trial recorded significant benefits and improved memory and overall functioning of patients. The company is planning to make the patches available in the market soon.

Alzheimer''s disease is a progressive, degenerative disease that alters the brain, causing impaired memory, thinking and behaviour. Statistics show that around 18 million people worldwide have Alzheimer''s disease, with the US alone reporting more than five million people suffering from the degenerative disease.

Commenting on the approval, James Shannon, global head of development at Novartis Pharma said, "Exelon Patch addresses an important medical need by delivering a proven drug in an entirely new form that meets the needs of patients and their caregivers."