FDA Approves First Drug to Treat Tardive Dyskinesia

The FDA has approved Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia, a neurological disorder involving repetitive involuntary movements. Ingrezza is the first drug approved by the FDA to treat tardive dyskinesia.

The efficacy of Ingrezza was analyzed in a placebo-controlled clinical trial of 234 participants. After 6 weeks, individuals who received Ingrezza showed improvement in the severity of involuntary movements compared with those who received placebo.

Serious adverse effects that could occur with Ingrezza include sleepiness and heart rhythm problems. Ingrezza should not be taken by patients with congenital long QT syndrome or with abnormal heartbeats associated with a prolonged QT interval.

—Michael Potts

Reference:

FDA approves first drug to treat tardive dyskinesia [press release]. FDA. April 11, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm552418.htm.