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May 16, 2006 1:04 pm US/Eastern
Vote Set On Drug For Parkinson's Dementia
WASHINGTON (AP) ―
A drug that treats mild to moderate dementia in Alzheimer's disease patients appears to be effective in helping Parkinson's patients with dementia as well, though researchers are not sure the two conditions are distinct, according to Food and Drug Administration documents released Tuesday.
Novartis AG seeks FDA approval to sell Exelon as a treatment for the 20 percent to 60 percent of Parkinson's patients the company estimates suffer from dementia. In 2000, the FDA approved the drug, also called rivastigmine, for Alzheimer's patients with dementia.
A newly released FDA review found the drug is effective in treating dementia in Parkinson's patients as well. That finding is not "totally unexpected," reviewers said.
But reviewers held off on recommending the drug be approved for that new use pending a meeting of the agency's Peripheral and Central Nervous Systems Drugs advisory committee. The outside panel of experts is to meet Wednesday and vote on a recommendation to the agency. The FDA isn't required to follow the recommendations of its panels of experts but usually does.
However, in documents posted Tuesday to the FDA Web site, reviewers questioned whether Parkinson's-related dementia was any different from that associated with Alzheimer's. The advisory committee is asked to take up that question Wednesday.
"Is there a distinct form of dementia associated with Parkinson's disease (and, in particular, a dementia that is distinct from Alzheimer's disease) and do widely accepted, valid and reliable criteria exist for its clinical diagnosis?" FDA staff asked the panel.
Currently, there are no FDA-approved drugs to treat mild to moderate dementia in Parkinson's patients. Five drugs, including Exelon, have been approved for Alzheimer's-related dementia.
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