FDA approves Teva movement disorder treatment

Teva Photo: Reuters
Teva Photo: Reuters

Branded drug AUSTEDO had also previously been approved for the treatment of chorea associated with Huntington’s disease.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has announced that the US Food and Drug Administration (FDA) has approved AUSTEDO (deutetrabenazine) tablets for the treatment of tardive dyskinesia in adults. AUSTEDO had been previously also 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 US and is caused by certain medications used to treat mental health conditions or gastrointestinal conditions.

Teva president Global R&D and CSO Dr. Michael Hayden said, “We are pleased to bring forward this second indication for AUSTEDO to treat the underserved tardive dyskinesia population. 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.

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

Published by Globes [online], Israel business news - www.globes-online.com - on August 31, 2017

© Copyright of Globes Publisher Itonut (1983) Ltd. 2017

Teva Photo: Reuters
Teva Photo: Reuters
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