Ingrezza, a Neurocrine Biosciences Drug, Receives FDA Approval for Tardive Dyskinesia Treatment

1. Neurocrine Biosciences, a biopharmaceutical company, has received FDA approval for its drug Ingrezza (valbenazine) to treat tardive dyskinesia, a neuropsychiatric disorder.
2. Ingrezza is the first-of-its-kind treatment approved by the FDA for tardive dyskinesia, a condition characterized by involuntary, repetitive movements.
3. Tardive dyskinesia is a side effect of prolonged use of antipsychotic medications, which are often used to treat mental health conditions such as schizophrenia and bipolar disorder.
4. Ingrezza works by selectively inhibiting the vesicular monoamine transporter 2 (VMAT2), which is responsible for packaging and transporting monoamines, including dopamine, in the brain.
5. The FDA approval was based on the results of two Phase 3 clinical trials, KINECT 3 and KINECT 4, which demonstrated the efficacy and safety of Ingrezza in reducing the severity of tardive dyskinesia symptoms.
6. Ingrezza is expected to be available in the U.S. in the second quarter of 2017.