FDA moves forward with Teva's application for tardive dyskinesia drug

The FDA has approved the New Drug Application from Teva Pharmaceutical Industries Ltd. and granted Priority Review for SD-809, a treatment for tardive dyskinesia. 
With a Prescription Drug User Fee Act goal date of Aug. 30, Teva anticipates that the drug will be available soon. 
The application for the drug was reliant on two Phase III studies, ARM-TD (Aim To Reduce Movements in Tardive Dyskinesia) and AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia). The Priority Review allows for certain medications to be evaluated more quickly, especially in drugs that have the potential to affect great changes in the treatment of serious conditions.
SD-809 has already been approved for Breakthrough Therapy Designation by the FDA. 
Dr. Michael Hayden, chief scientific officer at Teva, said the new drug will positively impact those suffering from tardive dyskinesia, a disorder that exhibits itself in uncontrollable and at times disabling ticks of the tongue, face, lips, trunk and extremities. 
"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," Hayden said.