NBIX - FDA accepts Neurocrine's supplemental application for movement disorder treatment
- Neurocrine Biosciences ( NASDAQ: NBIX ) on Thursday said the U.S. Food and Drug Administration (FDA) had accepted its supplemental new drug application (sNDA) for valbenazine as a treatment for movement disorder associated with Huntington's disease.
- The FDA is set to decide on the sNDA by Aug. 20, 2023, or the so-called Prescription Drug User Fee Act date.
- Huntington's disease is an inherited disease that causes progressive degeneration of nerve cells in the brain. It also causes chorea, or abnormal involuntary movement disorder.
- Valbenazine is also used to treat tardive dyskinesia, which is also another form of uncontrollable movement.
- "The sNDA filing included data from the KINECT™-HD Phase 3 study and the on-going KINECT™-HD2 open-label study of valbenazine in adults with chorea associated with Huntington disease," NBIX said in a statement .
- NBIX stock earlier closed +1.7% at $122.40.
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FDA accepts Neurocrine's supplemental application for movement disorder treatment