FDA to expedite review of Teva drug for movement disorder

28 Feb, 2017 9:31 pm

JERUSALEM – Israel-based Teva Pharmaceutical Industries said on Tuesday the U.S. Food and Drug Administration (FDA) has granted “priority review” for its SD-809 drug to treat tardive dyskinesia with a target date for approval by Aug. 30.

A priority, or expedited, review allows for a faster evaluation of drug applications.

Tardive dyskinesia, a condition for which there are no approved therapies in the United States, is a disorder characterized by repetitive and uncontrollable movements. It affects about 500,000 people in the United States and is usually a result of treatment with widely used medications for psychiatric conditions such as schizophrenia and bipolar disorder.

“There remains a significant unmet medical need in tardive dyskinesia,” said Michael Hayden, chief scientific officer at Teva. “SD-809 has the potential to reduce the severity of the abnormal involuntary movements of tardive dyskinesia which lead to social isolation for these patients.”


Teva’s new drug application for SD-809 is based on results from two late stage studies. -Reuters




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