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The FDA approval is supported by data from two clinical studies conducted in collaboration with the
"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
Key clinical trial outcomes from KINECT-HD include:
- INGREZZA 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 to –2.0; P < 0.0001).1,2
- INGREZZA reduced chorea severity by about 40 percent from baseline to maintenance (P < 0.0001) and nearly half of patients saw a more than 40 percent reduction in HD chorea severity by Week 12.1,2
- Fifty-three percent of patients and 43 percent of healthcare professionals reported overall HD chorea symptoms were "very much improved" or "much improved" at Week 12.1,2
Like other FDA-approved treatments for chorea associated with HD, the prescribing information for INGREZZA now includes important safety information regarding serious risk, including depression and suicidal ideation and behavior in patients with
In clinical studies in
See full Important Safety Information below.
"Clinical results that led to this important approval showed reduction in the severity of chorea as early as two weeks after starting INGREZZA at an initial dose of 40 mg, with consistently greater improvements versus placebo seen at all subsequent visits," said
"Chorea associated with HD can significantly affect the quality of life of a person living with HD by impacting their daily activities, social life, independence and overall well-being," said
The INBRACE® Support Program helps patients who are prescribed INGREZZA by assisting with product support and prescription fulfillment through a dedicated network of carefully selected specialty and local affiliated pharmacies. Patients with commercial insurance may be eligible for copay assistance and patients with no prescription coverage who also lack the financial resources to pay for their medicine may be eligible for participation in the patient assistance program. For more information, patients may visit INBRACESupportProgram.com/INGREZZAPatient/.
About Chorea Associated with Huntington's Disease (HD)
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.
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 KINECT-HD study was conducted in cooperation with the HSG and the Clinical Trials Coordination Center (CTCC) at the University of
About INGREZZA® (valbenazine) Capsules
INGREZZA is the only one-capsule, once-daily selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the
INGREZZA, developed by
INGREZZA® (valbenazine) capsules is a prescription medicine used to treat adults with:
- movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).
- involuntary movements (chorea) of
Huntington'sdisease. INGREZZA does not cure the cause of involuntary movements, and it does not treat other symptoms of Huntington'sdisease, such as problems with thinking or emotions.
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
Do not take INGREZZA if you:
- are allergic to valbenazine, or any of the ingredients in INGREZZA.
INGREZZA may cause serious side effects, including:
- Sudden swelling from an allergic reaction (angioedema). Sudden swelling has happened after the first dose or after many doses of INGREZZA. Signs and symptoms of angioedema include: swelling of your face, lips, throat, and other areas of your skin, difficulty swallowing or breathing, and raised, red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Go to the nearest emergency room right away if you develop these signs and symptoms. Your healthcare provider should stop your treatment with INGREZZA.
- Heart rhythm problems (QT prolongation). INGREZZA may cause a heart problem known as QT prolongation. Symptoms of QT prolongation may include: fast, slow, or irregular heartbeat, dizziness or fainting, or shortness of breath.
Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint.
- Neuroleptic Malignant Syndrome (NMS): NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, or increased sweating.
- Abnormal movements (Parkinson-like). Symptoms include: shaking, body stiffness, trouble moving or walking, or keeping your balance.
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
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 Neurocrine Biosciences, Inc.
NEUROCRINE, the Neurocrine logos, INGREZZA, the INGREZZA logos and KINECT are registered trademarks of
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA for the treatment of chorea associated with
- INGREZZA capsules (package insert).
San Diego, CA; Neurocrine Biosciences. 2023.
- Stimming EF, Claassen DO, Kayson E, et al. Safety and efficacy of valbenazine for the treatment of chorea associated with
Huntingtondisease (KINECT-HD): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2023;22(6): 494-504. doi:10.1016/S1474-4422(23)00127-8
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Neurocrine Biosciences, Inc.Media, Aimee White, 1-858-354-7865, firstname.lastname@example.org; Investors: Todd Tushla,1-858-617-7143, email@example.com