Teva scores expanded indication for Austedo in tardive dyskinesia
pharmafile | August 31, 2017 | News story | Sales and Marketing | FDA, Teva, medicine, pharma, pharmaceuticals
Following the FDA’s approval of Teva’s Austedo (deutetrabenazine) in the treatment of chorea associated with Huntington’s disease in April this year, the company has announced that the US regulator has also given the go-ahead for the use of the drug in the treatment of tardive dyskinesia (TD) in adults.
The decision by the FDA was based on the efficacy and safety results of two Phase III trials, measuring the drug’s ability to reduce the severity of abnormal involuntary movements associated with TD.
TD is characterised by these uncontrollable movements of the tongue, face and extremities, caused as a side-effect by medications used to treat mental health or gastrointestinal conditions. It affects around half a million people in the US alone.
“We are pleased to bring forward this second indication for Austedo to treat the underserved tardive dyskinesia population,” said Teva President Global R&D and CSO Dr Michael Hayden. “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.”
Rob Koreman, Teva Global Specialty Medicines CEO, added: “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.”
Matt Fellows
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