FDA to expedite review of Teva drug for movement disorder
TEL AVIV : Israel-based Teva Pharmaceutical Industries said 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 characterised 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.