Novartis' first Alzheimer's skin patch wins FDA approval

The US Food and Drug Administration (FDA) on Monday has approved Exelon Patch, the first skin patch that delivers a treatment for the most common type of dementia, Alzheimer's disease (AD), manufactured by Swiss drug maker Novartis AG.

Pharmaceutical group Novartis said yesterday that the US federal agency has given approval for Exelon Patch that can be used to treat dementia associated with mild-to-moderate Alzheimer's disease, giving patients an option to treat the chronic and progressive neurological condition through a once-daily skin patch instead of an oral capsule.

Basel-based drug company had put its new medication before the European Union in late 2006 for review.

The Exelon Patch contains the same drug, called Exelon or rivastigmine, which is currently available in capsule form. The difference is that the patch provides a regular and continuous dose throughout the day, according to Novartis.

The new therapy also slashes gastrointestinal side effects seen with oral form of drug, which directly enters the bloodstream when swallowed. The one-a-day skin patch, which is applied to the back, chest or upper arm, maintains steady drug levels in the bloodstream by providing smooth and continuous delivery of drug over 24 hours.

"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," said James Shannon, head of development at Novartis, in a statement.

In 2000, Exelon was approved by FDA in capsule form to treat Alzheimer's dementia and in 2006 to treat patients with mild to moderate dementia from Parkinson’s disease.

FDA’s approval for Novartis’ innovative skin patch is based on results from the international IDEAL (Investigation of Transdermal Exelon in ALzheimer's disease) clinical trial in which the researchers found the patch’s efficacy similar to the highest doses of Exelon capsules1.

The placebo-controlled clinical trial results showed significant benefits to nearly 1,200 patients with mild to moderate Alzheimer's disease, in terms of their memory and ability to perform everyday tasks as well as helping their overall functioning.

Alzheimer's disease is a neurodegenerative disease characterized by progressive cognitive deterioration together with declining activities of daily living and neuropsychiatric symptoms or behavioral changes. It is the most common type of dementia.

Besides progressive cognitive corrosion, loss of memory, and inhibited daily functioning, the other major symptoms of Alzheimer’s are aphasia, apraxia, agnosia. Impairment is also caused in the frontal and temporal lobes of the brain, fading decision-making and planning abilities.

The disease is characterized by the development of unusual clumps of proteins called amyloid plaques and nerve cell tangles that hinder messages being processed by the brain.

In 2004, Alzheimer’s was the 7th leading cause of death in USA, with 65,829 numbers of deaths. It is the third most costly disease in the U.S., after heart disease and cancer. Currently, nearly 4.5 million Americans have Alzheimer’s.

According to statistics, there are about 24 million people with dementia worldwide, and it has been projected that by 2040, the number of people suffering from AD will have increased to 81 million.

Globally, there are about 60% people in the developing countries affected by Alzheimer’s and by 2040; this proportion will rise to 71%.

In 2005, USA spent $76 billion to care for the Americans suffering from Alzheimer’s. It is expected that this figure is just one sixth of what the government will spent on the patients in 2007. Worldwide, about $315 billion was spent for the care and treatment of the people suffering from Alzheimer’s in 2005, and the figure is likely to increase like a mammoth in the present year.