TEVA's tardive dyskinesia drug wins FDA breakthrough status

TEVA's tardive dyskinesia drug, SD-809 has been granted breakthrough therapy designation by the FDA.

The designation comes on the back of data from the phase II/III Aim to Reduce Movements in Tardive Dyskinesia (ARM-TD) study which enrolled 117 patients with moderate to severe degrees of the condition.

Michael Hayden, president of global R&D and chief scientific officer at TEVA, said: “The granting of breakthrough therapy designation by the FDA represents significant progress toward advancing the clinical program for SD-809, as a potential, much-needed treatment option for the underserved tardive dyskinesia patient population.

“We remain excited about studying this innovative compound across a number of indications.”

Tardive dyskinesia is a condition characterised repetitive and uncontrollable movements of the tongue, lips, face and extremities and has been associated with the use of anti-psychotic drugs.

The condition affects around 500,000 people in the United States.

Breakthrough Therapy Designation is granted to a drug that is intended to treat a serious condition and preliminary clinical evidence suggests that SD-809 (deutetrabenazine) may demonstrate substantial improvement over available therapy.