Industry Brief

FDA Grants Teva Priority Review for Tardive Dyskinesia Therapy

Teva Pharmaceutical Industries Ltd. on Tuesday announced that the Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for SD-809 (deutetrabenazine) for the treatment of tardive dyskinesia. The agency also granted a Priority Review designation for SD-809, which allows for a faster evaluation of applications for drugs that could lead to significant improvements of serious health conditions.

SD-809 is small-molecule inhibitor of the vesicular monoamine 2 transporter known as VMAT2.

The NDA for SD-809 is based on the results of two phase 3 studies, including the AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia) that involved 288 patients with moderate to severe TD. Results from the study showed that after 12 weeks of treatment, people who received daily doses of 12 mg, 24 mg, or 36 mg of SD-809 were at least twice as likely to show improvements in TD symptoms than those who received placebo.

According to a press release by Teva, the FDA is expected to make a final decision on SD-809 for the treatment of TD by August 30. ■