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FDA Rejects Parkinson's Drug

Wednesday, 19 Oct 2011 10:13 AM

In a setback for Parkinson's treatment, a federal health panel refused to approve the use of the drug Azilect to slow progression of disease.
The medication is already approved for treatment of the symptoms of Parkinson’s disease, but the Food and Drug Administration ruled that there is not enough evidence that Azilect actually affects the underlying causes of the disease. Parkinson’s is marked by tremors, muscle stiffness, and movement problems. Currently, there are no approved treatments that slow or stop the course of the disease.
A panel of 17 outside experts for the FDA voted unanimously that the Israeli company that makes Azilect clinical studies do not show evidence that the medication slows the progression of the disease.
“I believe the drug shows signs of effectiveness for symptomatic use, for which it is already approved. But the higher bar is whether it does anything for disease modification, and it did not meet that standard,” Dr. Justin Zivin of the University of California, San Diego, said.
The study followed the effect of Azilect on 1,176 patients suffering from the early stages of Parkinson’s disease, who had not sought previous treatment.



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2011-13-19
Wednesday, 19 Oct 2011 10:13 AM
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