Reviewers for the US Food and Drug Administration (FDA) say that Teva Pharmaceutical Industries Ltd's (Nasdaq: TEVA; TASE: TEVA) Azilect for the treatment of symptoms of Parkison's disease fails to slow its progression, implying that the FDA will reject the drug's expanded use.
Teva has asked the FDA to expand approval so that it can be prescribed to slow the underlying disease, which slowly breaks down brain cells that control movement. Currently no treatments are approved for this indication.
The FDA said that the results of the efficacy trial of Azilect to slow the progression of Parkinson's disease were mixed, with widely disparate results between men and women and varying degrees of symptoms among patients studied. The FDA said that a one milligram dose of the drug appeared to slow patients' disease, but the two milligram dose of the drug failed to show similar results.
In a brief statement, the FDA said, "The failure of the two mg group raises serious questions about the interpretation of this study, and, therefore, about whether or not rasagiline has been shown to have disease-modifying effects. There is no obvious biological explanation for why the 2 mg dose should not be disease-modifying, if the 1 mg dose is." The FDA, acknowledged, however, that there were no firm criteria for measuring a drug's ability to slow Parkinson's disease.
The clinical trial included 1,176 patients with very early Parkinson's disease, who had not been treated previously.
Published by Globes [online], Israel business news - www.globes-online.com - on October 16, 2011
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