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news.Novartis' neurological drug Exelon has received a favorable opinion from a specialist FDA committee for the treatment of mild to moderate dementia associated with Parkinson's disease.
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The recommendation will be taken into account by the FDA when deciding whether or not to approve the expanded indication for the drug, which is already approved for the treatment of mild to moderate Alzheimer's disease. A final decision is expected in the third quarter of this year.
If approved, Exelon would be the first and only medication available specifically for the treatment of dementia associated with Parkinson's disease.
About 40% of patients with Parkinson's disease are estimated to also develop dementia, which can have a devastating effect on patients and their families. The risk of developing dementia among Parkinson's patients is approximately four to six times higher than among elderly people without this disease.
“We will continue to work closely with the FDA as the agency finalizes its review of Exelon for the treatment of Parkinson's patients with dementia,” said Alex Gorsky, head of pharma North America and CEO of Novartis.