Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending that the European Commission grant a marketing authorisation for Exelon (rivastigmine tartrate) for the symptomatic treatment of mild to moderately severe dementia associated with idiopathic Parkinson's disease (PD).

This decision coincides with the approval of Exelon as the first treatment for dementia associated with PD in Switzerland. Exelon already received marketing authorisation for this indication in several Latin American countries, including Brazil. This makes Exelon, currently indicated for Alzheimer's dementia, the only cholinesterase inhibitor to be authorised for more than one type of dementia, according to a Novartis release.

"This is encouraging news for Parkinson's patients who are affected by dementia. Although movement symptoms of Parkinson's disease can be managed quite well with current treatments, dementia associated with Parkinson's disease could not be treated until now. Novartis hopes that Exelon will soon be approved for this new indication in many more countries around the world," said James Shannon, global head of development, Novartis Pharma AG.

Since 1997, Exelon has been widely used to treat mild to moderate Alzheimer's disease dementia in over 70 countries. It belongs to a class of drugs known as cholinesterase inhibitors (ChEIs) which increases the communication between certain nerve cells in the brain.

Exelon is the first medication worldwide that has also shown significant benefits in the treatment of Parkinson's patients suffering from dementia in a large-scale, randomised, well-controlled study involving 541 patients from 12 study centres in Europe and Canada.

"Dementia associated with Parkinson's disease is a significant emotional, economic and social burden for patients and their families. We therefore welcome therapies like Exelon which give new hope to families caring for a loved one with dementia and may improve the quality of life of the whole family," said Mary Baker, president of the European Parkinson's Disease Association, London.

Exelon is a treatment for mild to moderate Alzheimer's disease. It belongs to a class of drugs known as cholinesterase inhibitors (ChEI's) which increase the activity of the neurotransmitter acetylcholine in the brain. Among the widely used ChEI's, Exelon is the only treatment that inhibits both enzymes involved in the breakdown of this neurotransmitter - acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE).