Neurocrine Biosciences, Inc., a leading neuroscience-focused biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for valbenazine as a treatment for chorea associated with Huntington disease (HD). The agency set a Prescription Drug User Fee Act (PDUFA) target action date of August 20, 2023.
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. Huntington disease is a hereditary, progressive neurodegenerative disorder. Approximately 90% of adults with HD experience chorea, an abnormal involuntary movement disorder.
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“This sNDA filing advances our effort to bring a potential new treatment option to the many thousands of people experiencing chorea associated with Huntington disease in the U.S.,” said Eiry W. Roberts, M.D. Chief Medical Officer at Neurocrine Biosciences. “We look forward to working with the FDA as it reviews our filing.”
The sNDA for valbenazine for the treatment of chorea associated with Huntington disease is supported by data from two clinical studies, including the Phase 3 KINECT-HD study and the on-going KINECT-HD2 open-label rollover study, with more than 150 patients with Huntington disease. The KINECT-HD study was a Phase 3, randomized, double-blind placebo-controlled study to evaluate the efficacy, safety, and tolerability of valbenazine as a treatment for chorea associated with Huntington disease. Approximately 128 adults 18 to 75 years of age who had been diagnosed with manifest HD and who had chorea symptoms were enrolled in the study and received once daily valbenazine or placebo for 12 weeks. KINECT-HD2 is an open-label study of approximately 150 patients for continuing valbenazine administration for the treatment of chorea associated with Huntington disease for up to 156 weeks. The primary endpoint in both studies was the change from baseline to maintenance in the Unified Huntington’s Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score. Data from these studies along with the results from a PK study were included in the sNDA submission.
SOURCE: PR Newswire