FDA Approves AUSTEDO® (deutetrabenazine) Tablets for the Treatment of Tardive Dyskinesia in Adults

Aug 31, 2017

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (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 Chief Scientific Officer 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.”

The approval was based on results from two Phase III randomized, double-blind, placebo-controlled, parallel group studies assessing the efficacy and safety of AUSTEDO® in reducing the severity of abnormal involuntary movements associated with tardive dyskinesia (AIM-TD and ARM-TD).

“Our medical and commercial teams are looking forward to bringing this new treatment to patients and physicians working to manage tardive dyskinesia,” said Rob Koremans, M.D., President and CEO of Global Specialty Medicines at Teva. “The launch of AUSTEDO®demonstrates our continued commitment to the treatment of movement disorders.”

Teva offers Shared Solutions®, a free service to provide support to patients starting or taking AUSTEDO®. The toll-free number for Shared Solutions® is 1-800-887-8100.

Source: News Release
Business Wire
August 30, 2017