Teva Pharmaceutical Industries Ltd. announced that the U.S. FDA has approved AUSTEDO (deutetrabenazine) tablets for the treatment of tardive dyskinesia in adults. AUSTEDO was previously approved for the treatment of chorea associated with Huntington’s disease in April 2017.
Tardive dyskinesia is a debilitating and often irreversible movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities. The condition affects about 500,000 people in the United States and can be caused by certain medications used to treat mental health conditions or gastrointestinal conditions.
“We are pleased to bring forward this second indication for AUSTEDO® to treat the underserved tardive dyskinesia population,” said Michael Hayden, M.D., Ph.D., president of Global R&D and CSO at Teva. “We believe physicians treating tardive dyskinesia will appreciate the therapy’s dosing flexibility and the ability to focus on directly treating the movement disorder and not disrupt the ongoing treatment for the underlying condition.”