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

Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9147451-neurocrine-biosciences-fda-approval-ingrezza/ 

The 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 

"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."

About Chorea Associated with Huntington's Disease (HD)
Huntington's disease (HD) is a hereditary progressive neurodegenerative disorder in which the loss of certain neurons within the brain causes motor, cognitive and psychiatric symptoms. Symptoms generally appear between the ages of 30 and 50 years and worsen over a 10- to 25-year period. Most people with HD experience chorea, an abnormal involuntary movement disorder, characterized by irregular and unpredictable movements. Chorea can affect various body parts and interfere with motor coordination, gait, swallowing and speech. HD is estimated to affect approximately 41,000 adults in the U.S., with more than 200,000 at risk of inheriting the disease.

About the KINECT®-HD Study
KINECT®-HD is a Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of valbenazine as a once-daily treatment to reduce chorea associated with Huntington's disease (HD) and evaluate the safety and tolerability of valbenazine in patients with HD. The study enrolled 128 adults 18 to 75 years of age who were diagnosed with motor-manifest HD and who had sufficient chorea symptoms to meet study protocol criteria.

KINECT-HD used the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) score as the primary efficacy endpoint. The secondary endpoints included Clinical Global Impression of Change (CGI-C) response status and Patient Global Impression of Change (PGI-C) response status for valbenazine treatment. Treatment with valbenazine resulted in a placebo-adjusted mean reduction in the TMC score of 3.2 units (P < 0.0001), indicating a highly statistically significant improvement in chorea. Secondary endpoints of CGI-C response status and PGI-C response status were also statistically significant and supported the improvements in TMC score that were seen over the 12-week study period.

Treatment-emergent adverse events in this study were generally consistent with the known safety profile of valbenazine. No suicidal behavior or worsening of suicidal ideation were observed in the valbenazine-treated participants in this study.

View the complete study results from the Phase 3 KINECT-HD study published in The Lancet Neurology online edition. For more information on the KINECT-HD study, please visit HuntingtonStudyGroup.org.

About KINECT®-HD2
KINECT®-HD2 is an ongoing open-label study to evaluate the long-term safety and tolerability, as well as the maintenance of effects, of INGREZZA in patients with chorea associated with Huntington's disease (HD). The 156-week study will enroll more than 150 adults 18 to 75 years of age who have been diagnosed with motor-manifest HD and who have sufficient chorea symptoms to meet study protocol criteria. Concomitant antipsychotic use is allowed in the study. For more information on the KINECT-HD2 study, please visit HuntingtonStudyGroup.org or ClinicalTrials.gov.

About Huntington Study Group/HSG Clinical Research, Inc. 
The Huntington Study Group (HSG), a not-for-profit organization founded in 1993 in Rochester, NY, and its wholly owned subsidiary, HSG Clinical Research, Inc., designs and conducts clinical trials through the world's first and largest collaborative network with thousands of members at more than 130 HSG credentialed research sites worldwide. HSG is dedicated to improving the lives of people impacted by Huntington's disease through research, education, and collaboration. For more information, visit HuntingtonStudyGroup.org. 

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