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INGREZZA® (valbenazine) capsules

Efficacy in adults with Huntington’s disease chorea

SELECT EFFICACY ENDPOINT:

TMC reduction

TMC response

CGI-C/PGI-C

TMC reduction

TMC reduction

TMC response

CGI-C/PGI-C

Proven Huntington’s disease (HD) chorea control: Rapid and sustained chorea reductions observed with INGREZZA as early as Week 2 and through Week 121,2

Mean change in Total Maximal Chorea score over time1,2

Mean change in Total Maximal Chorea score over time, chart
Mean change in Total Maximal Chorea score over time, chart

INGREZZA

REDUCED CHOREA

SEVERITY BY

~40%

FROM BASELINE TO END
OF TREATMENT1-3,*

*Post hoc analysis.

aP<0.0001.

Baseline is the average of screening and Day –1 assessments; end of treatment is the average of Week 10 and Week 12 assessments.

TMC, Total Maximal Chorea; SEM, standard error of mean; LS mean, least squares mean.

STUDY DESIGN

TMC SCALE INFORMATION

aP<0.0001.

Baseline is the average of screening and Day –1 assessments; end of treatment is the average of Week 10 and Week 12 assessments.

TMC, Total Maximal Chorea; SEM, standard error of mean; LS mean, least squares mean.

Nearly half of patients saw a >40% reduction in Huntington’s disease (HD) chorea severity with INGREZZA3,†

Distribution of percent change in TMC scores from baseline to end of treatment3

Percent improvement in TMC Score, graph
Percent improvement in TMC Score, graph

STUDY DESIGN

TMC SCALE INFORMATION

†

Post hoc analysis included patients who had a baseline and an end of treatment TMC score (n=112).

Baseline is the average of screening and Day –1 assessments; end of treatment is the average of the Week 10 and Week 12 assessments.

Greater than 80% of subjects were at the 80 mg dose at the end of the 12-week treatment period.

TMC, Total Maximal Chorea.

Physicians and patients reported significant improvements in overall chorea symptoms1,2

More physicians and patients rated overall symptoms of chorea as “very much improved” or “much improved” with INGREZZA® (valbenazine) capsules vs placebo at Week 121,2

CGI-C response rates‡

43% INGREZZA CGI-C response rate 13% placebo CGI-C response rate

P<0.001.

PGI-C response rates‡

53% INGREZZA PGI-C response rate 26% Placebo PGI-C response rate

P<0.01.

STUDY DESIGN

CGI-C/PGI-C INFORMATION

‡

Response was defined as “very much improved” or “much improved” at Week 12.

CGI-C, Clinical Global Impression of Change; PGI-C, Patient Global Impression of Change.

‡

Response was defined as “very much improved” or “much improved” at Week 12.

CGI-C, Clinical Global Impression of Change; PGI-C, Patient Global Impression of Change.

STUDY DESIGN

CGI-C/PGI-C INFORMATION

Watch expert perspective videos on INGREZZA

Featuring Steven Lo, MD; Lawrence Elmer, MD, PhD; Bisena Bulica, DO

These videos were sponsored and developed by Neurocrine Biosciences.
The speakers are paid consultants of Neurocrine Biosciences.

About the KINECT-HD pivotal study

Lawrence Elmer, MD, PhD; Steven Lo, MD; and Bisena Bulica, DO, discuss the KINECT-HD pivotal study

Efficacy and safety of INGREZZA in patients
with HD chorea

Lawrence Elmer, MD, PhD, and Steven Lo, MD, discuss INGREZZA in patients with HD chorea

THERAPEUTIC DOSE FROM DAY 1

The only VMAT2 inhibitor that offers an effective starting dosage you can adjust based on response and tolerability1

DOSING INFO

SEE PATIENT CASES
FROM KINECT-HD

View videos of clinical trial patients with HD chorea treated with INGREZZA

CASE VIDEOS

INGREZZA CLINICAL
SAFETY DATA

INGREZZA was studied across a broad range of patients with HD chorea

SAFETY PROFILE

REFERENCES:

  1. INGREZZA [package insert]. San Diego, CA: Neurocrine Biosciences, Inc.
  2. Stimming EF, Claassen DO, Kayson E, et al. Safety and efficacy of valbenazine for the treatment of chorea associated with Huntington’s disease (KINECT-HD): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2023;22(6):494-504.
  3. Data on file. Neurocrine Biosciences, Inc.
  4. Unified Huntington’s Disease Rating Scale: reliability and consistency. Huntington Study Group. Mov Disord. 1996;11(2):136-142.
  5. Guy W. ECDEU Assessment Manual for Psychopharmacology. Revised 1976. Rockville, MD: National Institute of Mental Health; 1976.

Important Information

INDICATION & USAGE

INGREZZA® (valbenazine) capsules and INGREZZA® SPRINKLE (valbenazine) capsules are indicated in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease.

IMPORTANT SAFETY INFORMATION

Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease.

CONTRAINDICATIONS

INGREZZA and INGREZZA SPRINKLE are contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE.

WARNINGS & PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions, including cases of angioedema involving the larynx, glottis, lips, and eyelids, have been reported in patients after taking the first or subsequent doses of INGREZZA. Angioedema associated with laryngeal edema can be fatal. If any of these reactions occur, discontinue INGREZZA or INGREZZA SPRINKLE.

Somnolence and Sedation

INGREZZA and INGREZZA SPRINKLE can cause somnolence and sedation. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA or INGREZZA SPRINKLE.

QT Prolongation

INGREZZA and INGREZZA SPRINKLE may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA and INGREZZA SPRINKLE should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.

Neuroleptic Malignant Syndrome

A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with drugs that reduce dopaminergic transmission, including INGREZZA. The management of NMS should include immediate discontinuation of INGREZZA or INGREZZA SPRINKLE, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems. If treatment with INGREZZA or INGREZZA SPRINKLE is needed after recovery from NMS, patients should be monitored for signs of recurrence.

Parkinsonism

INGREZZA and INGREZZA SPRINKLE may cause parkinsonism. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA or INGREZZA SPRINKLE treatment in patients who develop clinically significant parkinson-like signs or symptoms.

ADVERSE REACTIONS

The most common adverse reaction in patients with tardive dyskinesia (≥5% and twice the rate of placebo) is somnolence.

The most common adverse reactions in patients with chorea associated with Huntington’s disease (≥5% and twice the rate of placebo) are somnolence/lethargy/sedation, urticaria, rash, and insomnia.

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.

Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.

Please see full Prescribing Information, including Boxed Warning.

+Expand-Collapse

Important Safety Information

Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA, can increase the risk of depression and suicidal thoughts and

Important Information

INDICATION & USAGE

INGREZZA® (valbenazine) capsules and INGREZZA® SPRINKLE (valbenazine) capsules are indicated in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease.

IMPORTANT SAFETY INFORMATION

Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease.

Important Information

INDICATION & USAGE

INGREZZA® (valbenazine) capsules and INGREZZA® SPRINKLE (valbenazine) capsules are indicated in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease.

IMPORTANT SAFETY INFORMATION

Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease.

CONTRAINDICATIONS

INGREZZA and INGREZZA SPRINKLE are contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE.

WARNINGS & PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions, including cases of angioedema involving the larynx, glottis, lips, and eyelids, have been reported in patients after taking the first or subsequent doses of INGREZZA. Angioedema associated with laryngeal edema can be fatal. If any of these reactions occur, discontinue INGREZZA or INGREZZA SPRINKLE.

Somnolence and Sedation

INGREZZA and INGREZZA SPRINKLE can cause somnolence and sedation. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA or INGREZZA SPRINKLE.

QT Prolongation

INGREZZA and INGREZZA SPRINKLE may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA and INGREZZA SPRINKLE should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.

Neuroleptic Malignant Syndrome

A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with drugs that reduce dopaminergic transmission, including INGREZZA. The management of NMS should include immediate discontinuation of INGREZZA or INGREZZA SPRINKLE, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems. If treatment with INGREZZA or INGREZZA SPRINKLE is needed after recovery from NMS, patients should be monitored for signs of recurrence.

Parkinsonism

INGREZZA and INGREZZA SPRINKLE may cause parkinsonism. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA or INGREZZA SPRINKLE treatment in patients who develop clinically significant parkinson-like signs or symptoms.

ADVERSE REACTIONS

The most common adverse reaction in patients with tardive dyskinesia (≥5% and twice the rate of placebo) is somnolence.

The most common adverse reactions in patients with chorea associated with Huntington’s disease (≥5% and twice the rate of placebo) are somnolence/lethargy/sedation, urticaria, rash, and insomnia.

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.

Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.

Please see full Prescribing Information, including Boxed Warning.

KINECT®-HD: INGREZZA pivotal study design1,2

Study overview

KINECT-HD: INGREZZA pivotal study design for HD chorea, chart
KINECT-HD: INGREZZA pivotal study design for HD chorea, chart

Primary efficacy endpoint was the change in TMC score based on on-site assessments from the screening period baseline (the average of the screening and Day –1 assessments) to the average of the Week 10 and Week 12 assessments

During the dose-adjustment period, dose increases were allowed at the end of Weeks 2, 4, and 6, and to the next dose level if the subject tolerated the current dose

Subjects were maintained on a daily dose up to 80 mg during the maintenance period (beginning after the Week 8 visit through the end of Week 12)

The KINECT-HD pivotal study was a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of once-daily INGREZZA in subjects with HD chorea.

A total of 128 subjects were randomized into the study, and 125 subjects were included in the analysis of efficacy. The study included a 4-week screening period, an 8-week dose-adjustment period, a 4-week maintenance period, and a final study visit 2 weeks following the last dose of study drug. Individuals at significant risk for suicidal behavior and individuals with unstable psychiatric symptoms were excluded.

If the subject did not tolerate the current dose, the investigator could decrease the subject’s dose at any time during the dose adjustment period, which included Week 8. Greater than 80% of subjects were at the 80 mg dose at the end of the 12-week treatment period.

  • Doses were decreased 1 dose level at a time, and subjects could have multiple dose decreases during the dose adjustment period

Subjects who had a dose decrease could have their dose re-escalated during the dose adjustment period if the investigator considered that the dose increase would be reasonably tolerated.

Subjects who completed the study were eligible to enroll in a multi-year, open-label extension study to evaluate the long-term safety and effectiveness of INGREZZA for the treatment of HD chorea.

a

INGREZZA doses represent maximum daily doses during each period.

Select study baseline characteristics1,2

Select study baseline characteristics for HD chorea, chart
Select study baseline characteristics for HD chorea, chart

UHDRS, Unified Huntington’s Disease Rating Scale; TMC, Total Maximal Chorea; SD, standard deviation.

bFor screening period baseline (average of screening and Day –1 assessments).

Total Maximal Chorea scale4

The Total Maximal Chorea (TMC) score of the motor assessment on the Unified Huntington’s Disease Rating Scale (UHDRS) measures chorea across 7 body regions4

Each region is rated on a scale from 0 to 4, with 28 being the maximum score.

The Total Maximal Chorea (TMC) score

CGI-C/PGI-C scale information5

The CGI-C and PGI-C scales assess physician- and patient-rated improvement of overall chorea symptoms5

CGI-C, Clinical Global Impression of Change; PGI-C, Patient Global Impression of Change.

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