The Neurologix procedure delivers a gene (glutamic acid decarboxylase, or GAD) to the subthalamic nucleus of the brain—an area where brain chemicals that control motion interact. The gene instructs cells to form a chemical called GABA that helps to quiet the abnormal brain activity. This quieting is thought to be similar to the action deep brain stimulation therapy produces.
Fast track designation means the FDA will make special efforts to get a treatment through the approval process quickly. The agency is willing to make these concessions when a treatment has the potential to address unmet needs for a serious health condition.
There are few treatments for advanced Parkinson's disease. And existing treatments are not usually very effective. The Parkinson's community would like to see a treatment help people live better during the latter years of the illness.
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