The FDA has okayed valbenazine (Ingrezza), the first drug to treat tardive dyskinesia, the agency announced.
The small molecule drug, made by Neurocrine Biosciences, is an inhibitor of the vesicular monoamine 2 transporter (VMAT2) pathway, which plays a role in regulating dopamine levels in the brain.
Its efficacy was supported by a pivotal trial involving 234 patients that found that, over 6 weeks, those on the drug had improvements in the severity of abnormal involuntary movements compared with those on placebo. Those data were presented at last year's American Academy of Neurology meeting.
Side effects include sleepiness and QT prolongation, so the drug is contraindicated in patients with congenital long QT syndrome or with abnormal heartbeats associated with a prolonged QT interval, the agency said.
Also, the agency warned that patients shouldn't drive or operate heavy machinery until they know how the drug affects them.
Tardive dyskinesia, a neurological disorder characterized by repetitive involuntary movements, is often a side effect among patients taking antipsychotics, particularly older drugs such as chlorpromazine and haloperidol.
Valbenazine had been granted fast track, priority review, and breakthrough therapy designation from the FDA. Earlier this year, the agency had cancelled an advisory committee meeting for the drug.
Neurocrine could face competition from Teva's VMAT2 inhibitor deutetrabenazine, which was approved last week for treating Huntington's chorea. It is not yet approved for tardive dyskinesia, however.