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Neurocrine Biosciences Announces FDA Approval of INGREZZA® (valbenazine) Capsules for the Treatment of Chorea Associated With Huntington's Disease
SAN DIEGO, Aug. 18, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration (FDA) has approved
About this update from Neurocrine Biosciences, Inc.
[{"type":"text","content":"SAN DIEGO, Aug. 18, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration (FDA) has approved INGREZZA® (valbenazine) capsules for the treatment of adults with chorea associated with Huntington's disease (HD).1 INGREZZA is the only selective vesicular monoamine transporter 2 (VMAT2) inhibitor that offers an effective starting dosage that can be adjusted by a patient's healthcare provider based on response and tolerability, with no complex titration.1 Only INGREZZA offers simple dosing that is always one capsule, once daily.1\nExperience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9147451-neurocrine-biosciences-fda-approval-ingrezza/ \nThe FDA approval is supported by data from two clinical studies conducted in collaboration with the Huntington Study Group (HSG), including the KINECT®-HD Phase 3 study and the ongoing KINECT®-HD2 open-label extension trial.1,2 KINECT-HD, a randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of INGREZZA, met its primary endpoint of least squares mean (LSM) change in chorea severity using the Total Maximal Chorea (TMC) score of the Unified Huntington's Disease Rating Scale (UHDRS) from screening period baseline to maintenance period (average of Weeks 10 and 12), demonstrating a statistically significant greater improvement in TMC score with INGREZZA versus placebo.1,2 \n\"We are proud to bring INGREZZA to people living with HD and their caregivers who now have the option of a one-capsule, once-daily treatment that has demonstrated significant improvement in HD chorea in clinical studies,\" said Kevin C. Gorman, Chief Executive Officer, Neurocrine Biosciences. \"We are thankful for those in the HD community who helped contribute to this important milestone, and we remain committed to bringing medicines to patients with unmet medical needs for debilitating neurological disorders.\"\nKey clinical trial outcomes from KINECT-HD include:\nINGREZZA demonstrated a three-times greater improvement in chorea severity compared to placebo, with a 4.6-point improvement seen with INGREZZA versus a 1.4-point improvement with placebo in the chorea severity score from the start to the end of the 12-week clinical study (least squares mean difference –3.2, 95% CI, –4.4 t...