A US Food and Drug Administration advisory committee recommended approval of a new indication for Novartis’ Exelon yesterday after concluding it was effective in the treatment of dementia associated with Parkinson’s disease.
Exelon (rivastigmine), a cholinesterase inhibitor, is already approved to treat mild-to-moderate dementia caused by Alzheimer’s disease, and brought $467 million in worldwide sales to Novartis last year.
But sales of the drug have started to decline, slipping 1% to $116 million in the first quarter of 2006 and 13% to $42 million in the USA, and the product could do with a green light in Parkinson’s disease to give it a lift.
The panel voted unanimously that Exelon should be used to treat Parkinson’s patients with dementia, and if the FDA follows its lead Novartis’ drug will be the first to win approval for this indication. Approximately 1.5 million people in the USA have the disease, and around 40% of them have cognitive problems characteristic of dementia.
Ahead of the meeting, FDA reviewers questioned whether Exelon should be cleared, on the grounds that they were unsure whether there is a distinct form of dementia associated with Parkinson's and, if so, whether it can be reliably diagnosed.
Last month, Exelon was granted marketing authorisation for the treatment of dementia associated with Parkinson's disease in all 25 EU member states. It has also been cleared for this indication in 14 other countries around the world.