Teva's Drug Austedo FDA Nod For Label Expansion In Dyskinesia

Teva Pharmaceutical Industries Ltd. (TEVA – Free Report) announced that the FDA has approved a label expansion for its drug, Austedo. With the latest FDA approval, Austedo’s label has been expanded to include treatment of tardive dyskinesia, a debilitating and often irreversible movement disorder.

We remind investors that Austedo was approved for treating chorea associated with Huntington’s disease in April 2017. Both TD and chorea are characterized by involuntary or diminished voluntary movement of muscles.

Shares of the company are up almost 2.4% in pre-market trading. However, shares of Teva have underperformed the industry so far this year as it is facing challenges in the U.S. generic industry. The company’s shares have plunged 57.1% while the industry has lost 20.1% in that period.

Coming back to the news, the FDA approval for TD was based on data from two pivotal studies – AIM-TD and ARM-TD – demonstrating statistically significant reduction in severity of abnormal involuntary movements associated with tardive dyskinesia.

Teva’s chief scientific officer said that Austedo has a flexible dosing regimen and it also doesn’t affect the ongoing treatment for the underlying condition, which caused the TD disorder.

Teva is also evaluating Austedo in a phase I study for another involuntary movement disease, Tourette syndrome.

Per the company’s press release, TD affects approximately 500,000 people in the U.S. In April 2017, the FDA had approved Neurocrine Biosciences’ Ingrezza as a treatment for adults with TD, which is expected to give competition to Austedo in this indication.

Teva is offering free service to provide support to new patients as well as those already on Austedo therapy.

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