- Prescription Drug User Fee Act (PDUFA) Target Action Date Set
for April 30, 2024
SAN
DIEGO, Sept. 14, 2023 /PRNewswire/ --
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today
announced the U.S. Food and Drug Administration (FDA) has accepted
its New Drug Application (NDA) for INGREZZA®
(valbenazine) oral granules, a new sprinkle formulation of
INGREZZA® (valbenazine) capsules for oral
administration. The agency set a Prescription Drug User Fee Act
(PDUFA) target action date of April 30,
2024.
The INGREZZA oral granules capsules (40 mg, 60 mg and 80 mg) are
intended to be opened for sprinkling on soft foods prior to
administration. The NDA filing included chemistry, manufacturing,
and controls (CMC) information and data demonstrating the
bioequivalence and tolerability of the INGREZZA oral granule
sprinkle capsules compared to the currently approved INGREZZA
capsules.
"Patients with tardive dyskinesia or chorea associated with
Huntington's disease can experience dysphagia that can impact their
ability to swallow capsules," said Eiry W. Roberts, M.D., Chief
Medical Officer at Neurocrine Biosciences. "We developed this
potential new formulation of INGREZZA as an alternative
administration option for those patients who have difficulty
swallowing or simply prefer not to take whole capsules."
INGREZZA is currently available as the only one-capsule,
once-daily treatment option with no complex titration for adults
with tardive dyskinesia and the treatment of chorea associated with
Huntington's disease. It is the only selective vesicular monoamine
transporter 2 (VMAT2) inhibitor that offers three effective dosages
(40 mg, 60 mg and 80 mg) that can be adjusted by the healthcare
provider based on patient response and tolerability.
About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD)
is a movement disorder that is characterized by uncontrollable,
abnormal and repetitive movements of the face, torso and/or other
body parts, which may be disruptive and negatively impact patients.
The condition is associated with taking certain kinds of mental
health medicines (antipsychotics) that help control dopamine
receptors in the brain. Taking antipsychotics commonly prescribed
to treat mental illnesses such as major depressive disorder,
bipolar disorder, schizophrenia and schizoaffective disorder and
other prescription medicines (metoclopramide and prochlorperazine)
used to treat gastrointestinal disorders are associated with TD. In
patients with TD, these treatments are thought to result in
irregular dopamine signaling in a region of the brain that controls
movement. The symptoms of TD can be severe and are often persistent
and irreversible. TD is estimated to affect approximately 600,000
people in the U.S.
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 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 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, and INGREZZA 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 oral granules and the value
INGREZZA oral granules may bring to patients. Among the factors
that could cause actual results to differ materially from those
indicated in the forward-looking statements are: risks that
INGREZZA oral granules may not obtain regulatory approval, or that
the U.S. Food and Drug Administration or regulatory authorities
outside the U.S. may make adverse decisions regarding INGREZZA oral
granules; risks and uncertainties associated with the
commercialization of INGREZZA oral granules; risks that clinical
trial activities may not be predictive of real-world results or of
results in subsequent clinical trials; risks that INGREZZA oral
granules may be precluded from commercialization by the proprietary
rights of third parties, or have unintended side effects or adverse
reactions; risks and uncertainties relating to competitive products
and technological changes that may limit demand for INGREZZA oral
granules; risks associated with our dependence on third parties for
development and manufacturing activities related to INGREZZA oral
granules and our product candidates, and our ability to manage
these third parties; risks that the FDA or other regulatory
authorities may make adverse decisions regarding our products or
product candidates; risks that our products, and/or our product
candidates may be precluded from commercialization by the
proprietary or regulatory rights of third parties, or have
unintended side effects, adverse reactions or incidents of misuse;
risks associated with potential generic entrants for our products;
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.
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SOURCE Neurocrine Biosciences, Inc.