SAN DIEGO, Oct. 11, 2016 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) today announced that the U.S. Food
and Drug Administration (FDA) has accepted for Priority Review the
New Drug Application (NDA) for INGREZZATM (valbenazine)
for the treatment of tardive dyskinesia. The INGREZZA application
has been given a Prescription Drug User Fee Act (PDUFA) target
action date of April 11, 2017.
"This is another significant milestone for Neurocrine and more
importantly those patients who are suffering from tardive
dyskinesia," said Kevin C. Gorman,
President and Chief Executive Officer of Neurocrine Biosciences.
"We will continue to work with the FDA in their review of the
INGREZZA NDA to potentially bring this important treatment option
to patients and physicians."
A Priority Review designation accelerates the FDA review
timeline from 10 months to 6 months from the date of acceptance of
the NDA. The designation directs the FDA's overall attention and
resources to the evaluation of applications for drugs that, if
approved, would be a significant improvement in the safety or
effectiveness of the treatment of a serious condition. INGREZZA
(valbenazine) previously received Fast Track status and
Breakthrough Designation status from the FDA.
The NDA for INGREZZA includes the results from the Kinect 2 and
Kinect 3 clinical trials which evaluated over 330 tardive
dyskinesia patients. Data from these studies along with the results
from another 18 clinical trials, extensive preclinical testing and
drug manufacturing data were included in the NDA submission.
About Tardive Dyskinesia
Tardive dyskinesia is characterized by involuntary, repetitive
movements of the face, trunk, or extremities, including lip
smacking, grimacing, tongue protrusion, facial movements or
blinking, puckering and pursing of the lips. These symptoms are
rarely reversible and there are currently no FDA approved
treatments.
About INGREZZA
VMAT2 is a protein concentrated in the human brain that is
primarily responsible for re-packaging and transporting monoamines
(dopamine, norepinephrine, serotonin, and histamine) in
pre-synaptic neurons. INGREZZA (valbenazine or NBI-98854),
developed in the Neurocrine laboratories, is a novel,
highly-selective VMAT2 inhibitor that modulates dopamine release
during nerve communication, showing little or no affinity for
VMAT1, other receptors, transporters and ion channels. INGREZZA is
designed to provide low, sustained, plasma and brain concentrations
of active drug to allow for once daily dosing.
Modulation of neuronal dopamine levels in diseases such as
tardive dyskinesia, Tourette syndrome, Huntington's chorea,
schizophrenia, and tardive dystonia, which are characterized, in
part, by a hyperdopaminergic state, may provide symptomatic
benefits for patients with these diseases.
Neurocrine received Breakthrough Therapy Designation from the
FDA in 2014 for INGREZZA in the treatment of tardive dyskinesia.
The NDA for INGREZZA for the treatment of tardive dyskinesia is
currently under Priority Review with the FDA. The proprietary name
INGREZZA has been conditionally accepted by the FDA.
The Company is also investigating the safety and efficacy of
INGREZZA in the treatment of Tourette syndrome. The Company has two
ongoing placebo-controlled Phase II Tourette syndrome studies
evaluating INGREZZA in adults and pediatrics, the T-Forward study
and T-Force GREEN study, respectively. Each of these studies is
expected to enroll up to 90 subjects with Tourette syndrome.
Additionally, the Company has recently launched an open-label,
fixed-dose rollover study of INGREZZA in up to 180 subjects with
Tourette syndrome.
About Neurocrine Biosciences
Neurocrine Biosciences, Inc. discovers and develops innovative
and life-changing pharmaceuticals, in diseases with high unmet
medical needs, through its novel R&D platform, focused on
neurological and endocrine based diseases and disorders. The
Company's two lead late-stage clinical programs are elagolix, a
gonadotropin-releasing hormone antagonist for women's health that
is partnered with AbbVie Inc., and INGREZZA, a vesicular monoamine
transporter 2 inhibitor for the treatment of movement disorders.
Neurocrine intends to maintain certain commercial rights to its
VMAT2 inhibitor for evolution into a fully-integrated
pharmaceutical company.
Neurocrine Biosciences, Inc. news releases are available through
the Company's website via the internet at
http://www.neurocrine.com.
In addition to historical facts, this press release contains
forward-looking statements that involve a number of risks and
uncertainties. Among the factors that could cause actual results to
differ materially from those indicated in the forward-looking
statements are risks and uncertainties associated with Neurocrine's
business and finances in general, as well as risks and
uncertainties associated with INGREZZA development. Specifically,
the risks and uncertainties the Company faces include risks that
the INGREZZA NDA may not obtain regulatory approval from the FDA
for tardive dyskinesia or such approval may be delayed or
conditioned; risks that additional regulatory submissions may not
occur or be submitted in a timely manner; risks that that the
FDA or regulatory authorities outside the U.S. may make adverse
decisions regarding INGREZZA; risks that INGREZZA development
activities for Tourette syndrome may not be completed on time or at
all; risks that ongoing INGREZZA development activities may be
delayed for regulatory or other reasons; risks that ongoing or
future INGREZZA clinical trials may not be successful or replicate
previous clinical trial results, may fail to demonstrate that
INGREZZA is safe, tolerable or effective, or may not be predictive
of real-world results or of results in subsequent clinical trials;
risks that INGREZZA may be precluded from commercialization
by the proprietary rights of third parties, or have unintended side
effects, adverse reactions or incidents of misuse; risks associated
with the Company's dependence on third parties for development and
manufacturing activities related to INGREZZA; risks that the
Company will be unable to raise additional funding, if required, to
complete development of or commercialize INGREZZA; risks and
uncertainties relating to competitive products and technological
changes that may limit demand for INGREZZA; and other risks
described in the Company's quarterly report on Form 10-Q for the
quarter ended June 30, 2016.
Neurocrine disclaims any obligation to update the statements
contained in this press release after the date hereof.
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SOURCE Neurocrine Biosciences, Inc.