Teva Pharmaceutical Industries has announced the FDA has accepted the New Drug Application (NDA) and granted Priority Review for SD-809 (deutetrabenazine) for the treatment of tardive dyskinesia (TD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 30, 2017.
“Teva is committed to advancing new therapeutic options for patients with neurological and movement disorders. There remains a significant unmet medical need in tardive dyskinesia,” said Michael Hayden, M.D., Ph.D., president of Global R&D and chief scientific officer at Teva. “SD-809 has the potential to reduce the severity of the abnormal involuntary movements of tardive dyskinesia which lead to social isolation for these patients. Currently there is no approved therapy in the U.S. for TD and this important milestone brings Teva one step closer to making SD-809 available.”
The NDA for SD-809 is based on results from two phase III studies, ARM-TD (Aim to Reduce Movements in Tardive Dyskinesia) and AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia). A Priority Review is an expedited review granted by the FDA that allows for a faster evaluation of applications for drugs that could be significant improvements in the safety or effectiveness in the treatment of serious conditions. SD-809 was previously granted Breakthrough Therapy Designation by the FDA.