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
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."
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 Huntington's disease and Neuroleptic Malignant
Syndrome (NMS).
In clinical studies in Huntington's disease, treatment-emergent
adverse events included somnolence and sedation, urticaria, rash
and insomnia.
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 Erin Furr Stimming, M.D., FAAN,
FANA, Principal Investigator, Huntington Study Group and
Professor of Neurology, McGovern Medical, UTHealth Houston. "Data
also demonstrated INGREZZA was generally well tolerated and showed
clinically meaningful improvement in adults with chorea associated
with HD."
"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
Louise Vetter, President and Chief
Executive Officer of the Huntington's Disease Society of America. "The
approval of INGREZZA for HD chorea means that people living with HD
have a new treatment option to help manage their chorea symptoms,
which is a welcomed milestone in efforts to improve care for
families affected by HD."
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)
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.
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 INGREZZA® (valbenazine)
Capsules
INGREZZA is the only one-capsule, once-daily
selective vesicular monoamine transporter 2 (VMAT2) inhibitor
approved by the U.S. Food and Drug Administration for the treatment
of adults with tardive dyskinesia and the treatment of chorea
associated with Huntington's
disease (HD).
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
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's disease. INGREZZA does not cure
the cause of involuntary movements, and it does not treat other
symptoms of Huntington's disease,
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 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:
- 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
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 Neurocrine Biosciences, Inc.
Neurocrine
Biosciences is a leading neuroscience-focused, biopharmaceutical
company with a simple purpose: to relieve suffering for people with
great needs, but few options. We are dedicated to discovering and
developing life-changing treatments for patients with
under-addressed neurological, neuroendocrine, and neuropsychiatric
disorders. The company's diverse portfolio includes FDA-approved
treatments for tardive dyskinesia, chorea associated with
Huntington's disease, Parkinson's
disease, endometriosis* and uterine fibroids*, as well as a robust
pipeline including multiple compounds in mid- to late-phase
clinical development across our core therapeutic areas. For three
decades, we have applied our unique insight into neuroscience and
the interconnections between brain and body systems to treat
complex conditions. We relentlessly pursue medicines to ease the
burden of debilitating diseases and disorders, because you deserve
brave science. For more information,
visit Neurocrine.com, and follow the company on LinkedIn,
Twitter and Facebook. (*in collaboration with
AbbVie)
NEUROCRINE, the Neurocrine logos, INGREZZA, the INGREZZA logos
and KINECT are registered trademarks of Neurocrine Biosciences,
Inc.
Forward-Looking Statements
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 Huntington's
disease (HD), the size of the potential market for INGREZZA for the
treatment of chorea associated with HD; the value INGREZZA for the
treatment of chorea associated with HD brings to patients; the
ability of Neurocrine Biosciences to ensure patients have access to
INGREZZA for the treatment of chorea associated with HD; and
whether results from INGREZZA for the treatment of chorea
associated with HD clinical trials are indicative of real-world
results. Among the factors that could cause actual results to
differ materially from those indicated in the forward-looking
statements include: risks and uncertainties associated with
Neurocrine Biosciences' business and finances in general, as well
as risks and uncertainties associated with the commercialization of
INGREZZA for the treatment of chorea associated with HD; whether
INGREZZA for the treatment of chorea associated with HD receives
adequate reimbursement from third-party payors; the degree and pace
of market uptake of INGREZZA for the treatment of chorea associated
with HD; risks and uncertainties relating to competitive products
and technological changes that may limit demand for INGREZZA for
the treatment of chorea associated with HD; risks associated with
the Company's dependence on third parties for development and
manufacturing activities related to INGREZZA for the treatment of
chorea associated with HD, and the ability of the Company to manage
these third parties; risks that additional regulatory submissions
for INGREZZA for the treatment of chorea associated with HD or
other product candidates may not occur or be submitted in a timely
manner; risks that the FDA or other regulatory authorities may make
adverse decisions regarding INGREZZA for the treatment of chorea
associated with HD; risks that post-approval INGREZZA for the
treatment of chorea associated with HD commitments or requirements
may be delayed; risks that INGREZZA for the treatment of chorea
associated with HD may be precluded from commercialization by the
proprietary rights of third parties, or have unintended side
effects, adverse reactions or incidents of misuse; risks and
uncertainties relating to competitive products and technological
changes that may limit demand for INGREZZA for the treatment of
chorea associated with HD; and other risks described in the
Company's periodic reports filed with the Securities and Exchange
Commission, including without limitation the Company's quarterly
report on Form 10-Q for the quarter ended June 30, 2023. Neurocrine Biosciences disclaims
any obligation to update the statements contained in this press
release after the date hereof.
References
- 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
Huntington disease (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
©2023 Neurocrine Biosciences, Inc. All Rights Reserved.
CP-VBZ-US-2566 08/2023
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SOURCE Neurocrine Biosciences, Inc.