FDA approves Austedo for tardive dyskinesia
Teva Pharmaceuticals recently announced that the FDA approved Austedo tablets for the treatment of tardive dyskinesia in adults.
“We are pleased to bring forward this second indication for Austedo to treat the underserved tardive dyskinesia population,” Michael Hayden, MD, PhD, president of global research and development and chief scientific officer at Teva, said in a press release. “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.”
In April 2017, Austedo (deutetrabenazine, Teva Pharmaceuticals) was approved to treat chorea associated with Huntington’s disease.
The current approval is based on findings from two phase 3 randomized, double-blind, placebo-controlled, parallel group studies that indicated Austedo reduced the severity of abnormal involuntary movements associated with tardive dyskinesia.
“Our medical and commercial teams are looking forward to bringing this new treatment to patients and physicians working to manage tardive dyskinesia,” Rob Koremans, MD, president and CEO of Global Specialty Medicines at Teva, said in the release. “The launch of Austedo demonstrates our continued commitment to the treatment of movement disorders.”