Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new data on now FDA-approved INGREZZA® (valbenazine) capsules for the treatment of adults with chorea associated with Huntington’s disease (HD), including exploratory results from the Phase 3 KINECT®-HD study, which showed consistently greater improvements in HD chorea with INGREZZA versus placebo from Week 2 to Week 12.
Data Presented at the 2023 MDS International Congress of Parkinson’s Disease and Movement Disorders® SAN DIEGO, Aug. 28, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new data on now FDA-approved INGREZZA® (valbenazine) capsules for the treatment of adults with chorea associated with Huntington’s disease (HD), including exploratory results from the Phase 3 KINECT®-HD study, which showed consistently greater improvements in HD chorea with INGREZZA versus placebo from Week 2 to Week 12. These data will be presented at the MDS International Congress of Parkinson’s Disease and Movement Disorders® August 27-31 in Copenhagen, Denmark. “The exploratory analysis from our KINECT-HD study further exemplifies the value of INGREZZA as a now approved medication for HD chorea with improvements seen with treatment as early as two weeks,” said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. “Additional analyses presented add to the body of evidence regarding the use of INGREZZA for this patient population, including an increased understanding of Unified Huntington’s Disease Rating Scale (UHDRS®) Total Maximal Chorea (TMC) scores that signal clinically meaningful chorea improvements.” KINECT-HD, a Phase 3, randomized, double-blind, placebo-controlled study met its primary endpoint of chorea reduction as assessed using the UHDRS TMC score with a placebo-adjusted improvement of 3.2 points at Week 12 among those receiving INGREZZA. Secondary endpoints also demonstrated significantly greater improvements at Week 12 (ratings of “much improved” or “very much improved”) among those treated with INGREZZA compared with placebo as assessed using the Clinical Global Impression of Change (CGI-C; 42.9 percent versus 13.2 percent, respectively) and Patient Global Impression of Change (PGI-C; 52.7 percent versus 26.4 percent, respectively). These findings were recently published in The Lancet Neurology. The new exploratory analysis of KINECT-HD (Chorea Improvements Over Time With Once-Daily Valbenazine Treatment In Adults With Huntington Disease, poster # 879) showed greater placebo-adjusted improvement in chorea with INGREZZA at the lowest dose (40 mg) as early as the first treatment visit (Week 2), and greater efficacy compared to placebo was sustained through Week 12. The percentage of participants rated “much improved” or “very much improved” by CGI-C and PGI-C was consistently higher with INGREZZA than with placebo at all study visits. “The KINECT-HD study has provided valuable data regarding the safety and efficacy of INGREZZA for HD chorea in adults, and we continue to look at the data in new ways,” said Erin Furr Stimming, M.D., FAAN, FANA, Principal Investigator, Huntington Study Group and Professor of Neurology at McGovern Medical School, UTHealth Houston. “This exploratory analysis has increased our insight regarding the early and sustained improvements in chorea severity.” Additional HD chorea presentations at the MDS International Congress of Parkinson’s Disease and Movement Disorders include:
The full abstracts presented by Neurocrine Biosciences at the MDS International Congress of Parkinson’s Disease and Movement Disorders are available on the meeting website and can be accessed by registering. About Chorea Associated with Huntington’s Disease (HD) About KINECT®-HD 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 INGREZZA® (valbenazine) Capsules INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA selectively targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements. Additionally, INGREZZA can be taken for the treatment of tardive dyskinesia as one-capsule once-daily, together with most psychiatric medications such as antipsychotics or antidepressants. INGREZZA dosages approved for use are 40 mg, 60 mg and 80 mg capsules. INGREZZA is not approved in any other dosage form. Important Information Approved Uses
It is not known if INGREZZA is safe and effective in children. IMPORTANT SAFETY INFORMATION VMAT2 inhibitors, including INGREZZA, can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA if you have Huntington’s disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself. Do not take INGREZZA if you:
INGREZZA may cause serious side effects, including:
Before taking INGREZZA, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sleepiness (sedation) is a common side effect with INGREZZA. While taking INGREZZA, do not drive a car or operate dangerous machinery until you know how INGREZZA affects you. Drinking alcohol and taking other drugs that may also cause sleepiness while you are taking INGREZZA may increase any sleepiness caused by INGREZZA. The most common side effect of INGREZZA in people with tardive dyskinesia is sleepiness (somnolence). The most common side effects of INGREZZA in people with Huntington’s disease are sleepiness (somnolence), allergic itching, rash, and trouble getting to sleep or staying asleep. These are not all of the possible side effects of INGREZZA. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. Please see INGREZZA full Prescribing Information, including Boxed Warning. About Huntington Study Group / HSG Clinical Research, Inc. The KINECT-HD study was conducted in cooperation with the HSG and the Clinical Trials Coordination Center (CTCC) at the University of Rochester Medical Center’s Center for Health + Technology (CHeT). For more information, visit urmc.Rochester.edu/Health-Technology/Our-Expertise/Clinical-Trials-Coordination.aspx. About Neurocrine Biosciences, Inc. NEUROCRINE, the Neurocrine logos, INGREZZA, the INGREZZA logos and KINECT are registered trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements ©2023 Neurocrine Biosciences, Inc. All Rights Reserved. View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-new-ingrezza-valbenazine-capsules-data-demonstrating-early-and-sustained-improvements-in-chorea-associated-with-huntingtons-disease-301910386.html SOURCE Neurocrine Biosciences, Inc. | ||
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