FDA Rejects Expanded Designation for Parkinson's Treatment

Parkinson medication Azilect not found to slow disease progression

(RxWiki News) A U.S. Food and Drug Administration panel has unanimously voted to reject an expanded indication for Parkinson's drug rasagiline (Azilect).

The drug already was FDA approved for treating the signs and symptoms of Parkinson's disease, but drug maker Teva Pharmaceutical Industries, Ltd. had requested a label change stating that the medication slows the clinical progression of Parkinson's disease.

"Continue to use the medication as prescribed by your doctor."

The panel was not convinced that Teva's latest clinical trials proved that the drug can successfully slow progression of the neurodegenerative disease. No drug has yet been approved to receive such a label.

Azilect currently is on the market for symptoms related to Parkinson's disease including stiffness, impaired balance, trembling limbs and slow movement. 

In a joint statement, community Parkinson's organizations including the American Parkinson Disease Association, The
Michael J. Fox Foundation for Parkinson’s Research, the National Parkinson Foundation, the Parkinson’s Action Network, the Parkinson Alliance, and the Parkinson’s Disease Foundation. urged rigorous evaluation.

In the statement the groups said: “While we are encouraged by the evidence presented to date, it appears to our community that the data surrounding Azilect as a therapy that slows clinical progression of Parkinson’s are not yet definitive, and that additional information is required to completely determine the impact of Azilect on clinical disease progression.”

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Review Date: 
October 17, 2011